75
BIRTH 40:2 June 2013
Psychosocial Outcomes of a Randomized Controlled Trial of Outpatient Cervical Priming for Induction of Labor Deborah Turnbull, PhD, MAPS, Pamela Adelson, MPH, RN, Candice Oster, PhD, Robert Bryce, PhD, FRANZCOG, Jennifer Fereday, PhD, RN, and Chris Wilkinson, MPH, FRANZCOG ABSTRACT: Background: Induction of labor, an increasingly common intervention, is often
preceded by the application of an agent to “prime” or “ripen” the cervix. We conducted a randomized controlled trial to compare clinical, economic, and psychosocial outcomes of inpatient and outpatient cervical priming before induction of labor. In this paper we present the psychosocial outcomes. Methods: Women participating in a randomized controlled trial in two Australian metropolitan teaching hospitals completed questionnaires to measure anxiety and depression at enrollment, and to examine satisfaction, experiences, depression, and infant feeding 7 weeks after giving birth. Data analysis was by intention to treat and by having received the intervention as intended (approximately 50% in each group). Results: Of 1,004 eligible women, 85 percent consented (n = 407, outpatient; n = 414 inpatient). No statistically significant or clinically relevant differences were found in immediate anxiety, depression, or infant feeding. Small, statistically significant differences favoring outpatient priming were found in seven of the nine subscales in the 7-week postpartum questionnaire. The direction of the effect was maintained, mostly with a larger effect size in women who received the intervention. Conclusion: Women allocated to outpatient priming were more satisfied with their priming experience than women allocated to inpatient priming. Being informed that they could go home after cervical priming did not increase women’s anxiety. (BIRTH 40:2 June 2013) Key words: cervical priming, induction of labor, women’s satisfaction, psychosocial outcomes, randomized controlled trial Induction of labor is an increasingly common intervention in South Australia with almost one in three women having induction of labor (1). More than one-half of these inductions are preceded by the application of an
agent to soften or “ripen” the cervix (1). In South Australia it is usually performed as an inpatient procedure. An alternative is to allow women to go home after the insertion of the ripening agent (outpatient priming). It
Deborah Turnbull is a Professor in the School of Psychology at The University of Adelaide, Adelaide, South Australia; Pamela Adelson is a Research Associate in the School of Psychology at The University of Adelaide, Adelaide, South Australia; Candice Oster is a Visiting Research Fellow at the School of Psychology at The University of Adelaide, Adelaide, South Australia; Robert Bryce is Clinical Director of Obstetrics and Gynaecology at Flinders Medical Center and an Associate Professor at Flinders University, Adelaide, South Australia; Jennifer Fereday is Nursing and Midwifery Director, Clinical Practice Development, in the Nursing and Midwifery Clinical Practice Development Unit, Women’s and Children’s Hospital, Adelaide, South Australia; and Chris Wilkinson is Head of the Maternal-Fetal Medicine Unit at the Women’s and Children’s Hospital in Adelaide, South Australia, Australia.
Address correspondence to Deborah Turnbull, PhD, School of Psychology, The University of Adelaide, North Terrace, Adelaide, SA, 5005, Australia. The “Outpatient Priming for Induction of Labour” trial was funded by the National Health and Medical Research Council of Australia, Canberra, ACT, Australia, Project Grant 519236, and registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12608000249358). Accepted September 20, 2012 © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.
BIRTH 40:2 June 2013
76 has been proposed that outpatient priming may improve maternal satisfaction and convenience (2). The most recent Cochrane review of trials comparing inpatient and outpatient cervical priming concluded that the available data are too limited to establish the merits of outpatient priming (2). The authors also noted that little information is available on the psychosocial impact of outpatient priming despite the fact that one of the reasons for introducing this option has been to improve maternal satisfaction (2,3). The latest United Kingdom National Institute of Clinical Excellence Guidelines on induction of labor also emphasize the need for studies to assess the safety, clinical effectiveness, and cost effectiveness of outpatient and inpatient priming “taking into account women’s views” (4). We conducted a randomized controlled trial comparing inpatient and outpatient cervical priming for induction of labor. The aim of the trial was to compare clinical, economic, and psychosocial outcomes. In this paper we present the psychosocial outcomes, which addressed whether randomization to outpatient priming would increase women’s anxiety and whether outpatient priming improved satisfaction with care when compared with inpatient priming.
women to the labor ward or antenatal ward in the late afternoon or early evening. Midwives performed a vaginal assessment and at least 20 minutes of electronic fetal monitoring before inserting a prostaglandin E2 gel in the vagina. This procedure was followed by at least 20 minutes of electronic monitoring to confirm fetal well-being. The following morning, women underwent artificial rupture of the membranes (amniotomy) unless labor had started already or they needed another prostaglandin application. Amniotomy was followed by oxytocin infusion if labor did not ensue within a reasonable time. For women assigned to outpatient priming, cervical priming was followed by at least 40 minutes of electronic monitoring. If the monitoring was reassuring and uterine activity absent, the woman went home with written instructions from the midwife. Women presented to hospital the following morning or overnight if labor ensued. Women could telephone or return to hospital at any time.
Psychosocial Outcome Measures Enrollment questionnaire
Methods The trial was conducted in two metropolitan teaching hospitals in South Australia. To be eligible, women had to be aged 18 years or more, able to communicate in English, at low risk of obstetric complications, living within a 45-minute drive from the hospital, and being induced for postdate pregnancy or social reasons. Ethical approval was granted by the ethics committees of the two hospitals. An independent committee with power to stop the trial was established to monitor adverse events. Women were recruited between August 2008 and May 2011 from obstetric and midwifery clinics when induction was scheduled. Clinicians referred women to a designated research midwife who assessed eligibility. Eligible women were given oral and written information about the trial and were invited to participate. Consenting women were randomly allocated using a computer-generated process implemented by the Data Management and Analysis Centre at the University of Adelaide. Randomization was stratified by hospital and parity. Women were informed of their group allocation at the end of the recruitment interview.
Intervention The usual practice of cervical priming at the two hospitals, as in most Australian hospitals, was to admit
The enrollment questionnaire was given at the end of the trial entry interview and consisted of three previously validated scales: the Hospital Anxiety and Depression Scale the anxiety component of a Multiple Affect Adjective Check-List, and a 100 mm linear analog anxiety scale (5–7). Postpartum questionnaire A questionnaire was sent to women 7 weeks after giving birth. The questionnaire addressed satisfaction and experiences with care, current feeding practices (8), and the Edinburgh Postnatal Depression Scale (9). Questions about satisfaction and experiences with care were adapted from a questionnaire (10) based on a previous thematic analysis of 16 interviews with women who had experienced induction of labor (11). Thirty-eight items in the questionnaire were grouped into nine topics. Items were presented as complete statements with a 5-point Likert scale response format. A balance of positively and negatively worded items was included to reduce response bias. Two additional questions addressing concerns about returning to hospital were included for women in the outpatient group. Women (excluding two with an adverse birth outcome) were mailed the questionnaire. Telephone reminders were made after 3 weeks and a further questionnaire was sent if required. Women who scored
77
BIRTH 40:2 June 2013
more than 12 on the Edinburgh Postnatal Depression Scale (12) were reviewed by the research midwife and appropriate referrals made when needed.
Data Analysis We aimed to recruit 400 women per group to detect a reduction in oxytocin augmentation from 50 percent to 40 percent (80% power; a: 0.05). Data were analyzed according to the intention-to-treat principle including all randomized women. A separate analysis was also conducted for women who had received the priming intervention. Mean summated subscales were compared between the two groups with the Student two sample t test, with an F test for equal variances to determine whether homogeneity of variances could be assumed. The Cronbach alpha test was used to examine the internal reliability of the items addressing satisfaction and experiences with care. Statistical analyses were conducted with SPSS version 19.0 (SPSS Inc., Chicago).
Results Participants Of 1,084 women assessed for eligibility, 1,004 were eligible and 827 (82%) consented and were randomized. Four of them were ineligible immediately after randomization and two withdrew from the study, leaving 821 women in the final analysis (407 outpatient, 414 inpatient; Fig. 1). Overall, 51 percent allocated to inpatient and 53 percent allocated to outpatient priming did not receive prostaglandin gel because they had gone into labor or did not require cervical ripening before their scheduled induction. Baseline characteristics were similar in the two groups (Table 1).
Enrollment Questionnaire No difference was found between the two groups for anxiety or depression (Table 2). Women in both groups scored in the normal range (0-7) for anxiety and depres-
Referred for Eligibility N=1,084
n=80 not eligible n=27 spontaneous labor before consented n=150 declined to participate
Enrolled and Randomized n=827
n=416 Randomized Inpatient
n=411 Randomized Outpatient
n=1 ineligible (mistakenly randomized)
n=3 ineligible (mistakenly randomized)
Enrollment questionnaire response rate 99% (409/415)
Enrollment questionnaire response rate 99% (405/408)
n=1 withdrew, no outcome data available
n=1 withdrew permission (partner objected)
n=414 for final analysis
n=407 for final analysis
n=204 Did not require/receive priming intervention: n=195 spontaneous labor, ruptured membranes or cervix favorable n=5 medical complications n=3 declined to have induction n=1 wrong drug given (Cervidil)
n=210 (51%) Received priming gel
n=314 7-week postpartum questionnaire (76% overall response rate, 314/414 mailed)
Fig. 1. Flow of participants.
n=215 (53%) Received priming gel
n=192 Did not require/receive priming intervention: n=186 spontaneous labor, ruptured membranes or cervix favorable n=4 medical complications n=2 declined to have induction
n=306 7-week postpartum questionnaire (76% overall response rate, 306/405 mailed)
BIRTH 40:2 June 2013
78 sion on the Hospital Anxiety Depression Scale. Low anxiety scores were also recorded for both groups on the Multiple Affect Adjective Check-List and the linear analog anxiety scale.
Seven-Week Postpartum Questionnaire The postpartum questionnaire was sent to 819 women after excluding two women who had a poor pregnancy outcome (response rate: 76% in both groups). There were small statistically significant differences between the two groups for seven of the nine subscales with more favorable scores for women allocated to outpatient priming than for those allocated to inpatient primTable 1. Baseline Characteristics of Eligible Women
Characteristic Marital status Married /de facto Single (family supported) Single (unsupported) Language spoken at home English Other language Education Bachelor’s degree or higher Post-high school training High school only Employment Full-time Part-time Casual Not employed
Inpatient (n = 415) No. (%)
Outpatient (n = 408) No. (%)
379 (91) 24 (6) 10 (2)
371 (91) 27 (7) 7 (2)
343 (83) 72 (17)
324 (79) 84 (21)
137 (33) 121 (29) 156 (38)
157 (38) 98 (24) 148 (36)
130 65 37 174
149 54 29 164
(31) (16) (9) (42)
(37) (13) (7) (40)
*Maximum number of not stated for any variable n = 12 (employment).
ing (Table 3). No statistically significant differences were found for the subscales measuring “Environment” and “General Satisfaction.” The direction of effect was preserved with the effect often larger in the subgroup of women who received the intervention. However, no statistically significant differences were found for the subscales of Information and General satisfaction. There were no statistically significant or clinically relevant differences between the two groups for postpartum depression or infant feeding in either the intention-to-treat or treatment-received analyses (Table 4). Two questions specifically addressed potential concerns of women randomized to outpatient priming about making it back to hospital in time or how long to stay at home (Table 5). These analyses were confined to women who received the intervention. Women tended not to be worried about making it back in time and about how long to wait at home.
Discussion This study is the first to systematically compare the psychosocial impact of outpatient and inpatient priming for induction of labor. We analyzed data for all participants, although, in both groups, almost half of them did not need the intervention. Data were also analyzed for those who received the intervention. If outpatient priming is to be offered, it is important that it does not cause women undue anxiety. There is limited research on the acceptability of outpatient priming to women (13–16) and no studies have explored anxiety in women when randomized to inpatient or outpatient priming. Our results show that anxiety scores were low for both inpatient and outpatient women and that outpatient women did not have higher anxiety after being informed that they could go home after cervical priming when compared with inpatient women. An important objective of outpatient priming is to improve maternal satisfaction (2,3). Our findings support the results of previous research on women’s expe-
Table 2. Results of the Enrollment Questionnaire
Findings Hospital Anxiety Depression Scale Anxiety score (scale 0–21) Depression score (scale 0–21) Multiple adjective anxiety checklist 21 words (scale 0–21) Linear analog anxiety scale (scale 0–100 mm)
Inpatients Mean (SD) (n = 5.28 3.12 (n = 6.51 (n = 25.6
409) (3.09) (2.54) 407) (3.54) 405) mm (19.46)
Outpatients Mean (SD) (n = 5.32 3.20 (n = 6.62 (n = 25.7
405) (3.03) (2.66) 404) (3.46) 403) mm (18.91)
Mean difference (95% CI) 0.04 ( 0.46 to 0.38) 0.08 ( 0.43 to 0.27) 0.11 ( 0.59 to 0.37) 0.1 ( 2.75 to 2.55)
79
BIRTH 40:2 June 2013
riences of outpatient priming, which indicated that women were satisfied with the experience (14,15,17). Previous studies have often focused on outpatient
women alone. Only two studies assessed differences in maternal satisfaction between inpatient and outpatient priming (13,16) and they were limited in scope.
Table 3. Results of the Postpartum Questionnaire
Subscales Social support Environment Self-efficacy Readiness Stress Control Information Safety Satisfied
Inpatient N*, mean score (SD)
Outpatient N, mean score (SD)
n = 313 3.92 (0.80) n = 312 4.18 (0.73) n = 312 3.60 (0.84) n = 310 3.00 (0.89) n = 310 3.16 (0.92) n = 311 3.50 (0.80) n = 311 3.63 (0.74) n = 311 3.55 (0.80) n = 202 3.67 (0.88)
n = 305 4.17 (0.66) n = 304 4.24 (0.75) n = 305 3.77 (0.85) n = 304 3.18 (0.97) n = 304 3.37 (0.93) n = 304 3.63 (0.81) n = 304 3.80 (0.76) n = 305 3.72 (0.83) n = 197 3.83 (0.94)
Mean Difference (95% CI) 0.25 ( 0.13 to
0.37)
0.06 ( 0.18 to 0.06) 0.17 ( 0.03 to
0.30)
0.22 ( 0.07 to
0.37)
0.22 ( 0.07 to
0.36)
0.13 ( 0.003 to
0.26)
0.18 ( 0.06 to
0.29)
0.16 ( 0.03 to
0.29)
0.16 ( 0.33 to 0.02)
*Numbers vary with missing data for one or more of the subscale questions. Numbers for the subscale “satisfied” are less overall as many women who did not need an induction ticked the option “not applicable.”
Table 4. Postpartum Depression Scores and Data on Infant Feeding
Findings Edinburgh postnatal Depression scale Score 1 response) Type of infant feeding Fully breastfeeding Mostly* breastfeeding Mixed feeding Mostly* bottle feeding Fully bottle feeding Missing
Inpatients (n = 314)
Outpatients (n = 308)
234 25 20 28 5.81 4 7
(75%) (8%) (6%) (9%) (4.81) (0–26) (2%)
218 28 17 31 5.90 5 12
(71%) (9%) (6%) (10%) (4.53) (0–22) (4%)
182 23 25 8 73 3
(58%) (7%) (8%) (3%) (23%) (1%)
192 24 21 2 63 4
(63%) (8%) (7%) (1%) (20%) (1%)
*Mostly breastfeeding = about 4 out of 5 feedings daily. Mostly bottle feeding = 4 out of 5 feedings daily with bottle.
Table 5. Questionnaire Responses from Women who Received Outpatient Priming (n = 174)
No. (%) “I was worried that I would not make it back to hospital on time” Strongly agree Agree Not sure Disagree Strongly disagree Not applicable* Missing “I was worried about how long I should wait at home” Strongly agree Agree Not sure Disagree Strongly disagree Not applicable* Missing
9 14 8 70 45 27 1
(5) (8) (5) (40) (26) (16) (0.5)
11 34 5 66 27 30 1
(6) (20) (3) (38) (16) (17) (0.5)
*Women’s response to this question. Approximately 20% of women who received outpatient priming gel did not go home because of nonreassuring electronic fetal monitoring or because they changed their mind after receiving the gel.
BIRTH 40:2 June 2013
80 Responses to the postpartum questionnaire showed a small, statistically significant improvement in maternal satisfaction with outpatient priming for almost all aspects of care. There were no statistically significant or clinically relevant differences in Edinburgh Postnatal Depression Scale scores or infant feeding, a finding similar to that of other outpatient approaches which provide less medicalized care (18).
5.
6.
7.
Conclusion
8.
We have presented the psychosocial outcomes of a randomized controlled trial comparing inpatient and outpatient priming for induction of labor. The results indicate that women favored outpatient priming without increasing their anxiety when told they could go home after priming. In the subgroup analysis of women who received the intervention, the direction of the effect was maintained and the size of the effect often enlarged. The option of outpatient care instead of inpatient care appears to confer psychosocial benefit for women needing cervical priming before induction of labor.
9.
10. 11.
12.
13.
14.
Acknowledgments We thank the research midwives, Meredith Kelsey, Narelle de Sciscio, and Helen Pollard, and Philip Ryan, who provided protocol advice.
15.
References
16.
1. Scheil W, Scott J, Catcheside B, Sage L. Pregnancy Outcome in South Australia 2010. Adelaide: Pregnancy Outcome Unit, SA Health, Government of South Australia, 2012. 2. Kelly AJ, Alfirevic Z, Dowswell T. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev 2009; Issue 2, Art No.: CD007372. 3. Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev 2010; Issue 8, Art No.: CD007701. 4. National Collaborating Centre for Women’s and Children’s Health / National Institute for Health and Clinical Excellence
17.
18.
(NCCWCH/NICE). Induction of Labour. London: National Institute for Health and Clinical Excellence (NICE), 2008 Jul. p. 71 (Clinical guideline; no. 70). Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale: an updated literature review. J Psychosom Res 2002;52:69–77. Lubin B, Van Whitlock R, Reddy D, Petren S. A comparison of the short and long forms of the Multiple Affect Adjective Check List-Revised (MAACL-R). J Clin Psychol 2001;57:411–416. Elliott D. Comparison of the three instruments for measuring patient anxiety in a coronary care unit. Intensive Crit Care Nurs 1993;9:195–100. Labbok M, Krasovec K. Toward consistency in breastfeeding definitions. Stud Fam Plann 1990;21:226–230. Affonso DD, Anindya KD, Horowitz JA, Mayberry LJ. An international study exploring levels of postpartum depressive symptomatology. J Psychosom Res 2000;49:207–216. Turnbull D, Holmes A, Shields N, et al. Randomised, controlled trial of efficacy of midwife-managed care. Lancet 1996;348:213–218. Oster C, Adelson PL, Wilkinson C, Turnbull D. Inpatient versus outpatient cervical priming for induction of labour: therapeutic landscapes and women’s preferences. Health Place 2011;17:379– 385. Buist AE, Barnett EW, Milgrom J, et al. To screen or not to screen – that is the question in perinatal depression. Med J Aust 2002;177:S101–S105. Biem SR, Turnell RW, Olatunbosun O, Tauh M, Biem HJ. A randomized controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction. J Obstet Gynaecol Can 2003;25:23–31. Bollapragada SS, MacKenzie F, Norrie JD, et al. Randomised placebo-controlled trial of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour – clinical trial with analyses of efficacy and acceptability. The IMPO Study. BJOG 2009;116:1185–1195. Bullarbo M, Orrskog ME, Andersch B, Granstrom L, Norstrom A, Ekerhovd E. Outpatient vaginal administration of the nitric oxide donor isosorbide mononitrate for cervical ripening and labor induction postterm: a randomized controlled study. Am J Obstet Gynecol 2007;196:50.e1–50.e5. Awartani KA, Turnell RW, Olatunbosun OA. A prospective study of induction of labor with prostaglandin vaginal gel: ambulatory versus in-patient administration. Clin Exp Obstet Gynecol 1999;26:162–165. Reid M, Lorimer K, Norman JE, Bollapragada SS, Norrie J. The home as an appropriate setting for women undertaking cervical ripening before the induction of labour. Midwifery 2011;27: 30–35. Turnbull DA, Wilkinson C, Gerard K, et al. Clinical, psychosocial and economic effects of antenatal day care for three medical complications of pregnancy: a randomised controlled trial of 395 women. Lancet 2004;363:1104–1109.
BIRTH 40:2 June 2013
Psychosocial Outcomes of a Randomized Controlled Trial of Outpatient Cervical Priming for Induction of Labor Deborah Turnbull, PhD, MAPS, Pamela Adelson, MPH, RN, Candice Oster, PhD, Robert Bryce, PhD, FRANZCOG, Jennifer Fereday, PhD, RN, and Chris Wilkinson, MPH, FRANZCOG ABSTRACT: Background: Induction of labor, an increasingly common intervention, is often
preceded by the application of an agent to “prime” or “ripen” the cervix. We conducted a randomized controlled trial to compare clinical, economic, and psychosocial outcomes of inpatient and outpatient cervical priming before induction of labor. In this paper we present the psychosocial outcomes. Methods: Women participating in a randomized controlled trial in two Australian metropolitan teaching hospitals completed questionnaires to measure anxiety and depression at enrollment, and to examine satisfaction, experiences, depression, and infant feeding 7 weeks after giving birth. Data analysis was by intention to treat and by having received the intervention as intended (approximately 50% in each group). Results: Of 1,004 eligible women, 85 percent consented (n = 407, outpatient; n = 414 inpatient). No statistically significant or clinically relevant differences were found in immediate anxiety, depression, or infant feeding. Small, statistically significant differences favoring outpatient priming were found in seven of the nine subscales in the 7-week postpartum questionnaire. The direction of the effect was maintained, mostly with a larger effect size in women who received the intervention. Conclusion: Women allocated to outpatient priming were more satisfied with their priming experience than women allocated to inpatient priming. Being informed that they could go home after cervical priming did not increase women’s anxiety. (BIRTH 40:2 June 2013) Key words: cervical priming, induction of labor, women’s satisfaction, psychosocial outcomes, randomized controlled trial Induction of labor is an increasingly common intervention in South Australia with almost one in three women having induction of labor (1). More than one-half of these inductions are preceded by the application of an
agent to soften or “ripen” the cervix (1). In South Australia it is usually performed as an inpatient procedure. An alternative is to allow women to go home after the insertion of the ripening agent (outpatient priming). It
Deborah Turnbull is a Professor in the School of Psychology at The University of Adelaide, Adelaide, South Australia; Pamela Adelson is a Research Associate in the School of Psychology at The University of Adelaide, Adelaide, South Australia; Candice Oster is a Visiting Research Fellow at the School of Psychology at The University of Adelaide, Adelaide, South Australia; Robert Bryce is Clinical Director of Obstetrics and Gynaecology at Flinders Medical Center and an Associate Professor at Flinders University, Adelaide, South Australia; Jennifer Fereday is Nursing and Midwifery Director, Clinical Practice Development, in the Nursing and Midwifery Clinical Practice Development Unit, Women’s and Children’s Hospital, Adelaide, South Australia; and Chris Wilkinson is Head of the Maternal-Fetal Medicine Unit at the Women’s and Children’s Hospital in Adelaide, South Australia, Australia.
Address correspondence to Deborah Turnbull, PhD, School of Psychology, The University of Adelaide, North Terrace, Adelaide, SA, 5005, Australia. The “Outpatient Priming for Induction of Labour” trial was funded by the National Health and Medical Research Council of Australia, Canberra, ACT, Australia, Project Grant 519236, and registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12608000249358). Accepted September 20, 2012 © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.
BIRTH 40:2 June 2013
76 has been proposed that outpatient priming may improve maternal satisfaction and convenience (2). The most recent Cochrane review of trials comparing inpatient and outpatient cervical priming concluded that the available data are too limited to establish the merits of outpatient priming (2). The authors also noted that little information is available on the psychosocial impact of outpatient priming despite the fact that one of the reasons for introducing this option has been to improve maternal satisfaction (2,3). The latest United Kingdom National Institute of Clinical Excellence Guidelines on induction of labor also emphasize the need for studies to assess the safety, clinical effectiveness, and cost effectiveness of outpatient and inpatient priming “taking into account women’s views” (4). We conducted a randomized controlled trial comparing inpatient and outpatient cervical priming for induction of labor. The aim of the trial was to compare clinical, economic, and psychosocial outcomes. In this paper we present the psychosocial outcomes, which addressed whether randomization to outpatient priming would increase women’s anxiety and whether outpatient priming improved satisfaction with care when compared with inpatient priming.
women to the labor ward or antenatal ward in the late afternoon or early evening. Midwives performed a vaginal assessment and at least 20 minutes of electronic fetal monitoring before inserting a prostaglandin E2 gel in the vagina. This procedure was followed by at least 20 minutes of electronic monitoring to confirm fetal well-being. The following morning, women underwent artificial rupture of the membranes (amniotomy) unless labor had started already or they needed another prostaglandin application. Amniotomy was followed by oxytocin infusion if labor did not ensue within a reasonable time. For women assigned to outpatient priming, cervical priming was followed by at least 40 minutes of electronic monitoring. If the monitoring was reassuring and uterine activity absent, the woman went home with written instructions from the midwife. Women presented to hospital the following morning or overnight if labor ensued. Women could telephone or return to hospital at any time.
Psychosocial Outcome Measures Enrollment questionnaire
Methods The trial was conducted in two metropolitan teaching hospitals in South Australia. To be eligible, women had to be aged 18 years or more, able to communicate in English, at low risk of obstetric complications, living within a 45-minute drive from the hospital, and being induced for postdate pregnancy or social reasons. Ethical approval was granted by the ethics committees of the two hospitals. An independent committee with power to stop the trial was established to monitor adverse events. Women were recruited between August 2008 and May 2011 from obstetric and midwifery clinics when induction was scheduled. Clinicians referred women to a designated research midwife who assessed eligibility. Eligible women were given oral and written information about the trial and were invited to participate. Consenting women were randomly allocated using a computer-generated process implemented by the Data Management and Analysis Centre at the University of Adelaide. Randomization was stratified by hospital and parity. Women were informed of their group allocation at the end of the recruitment interview.
Intervention The usual practice of cervical priming at the two hospitals, as in most Australian hospitals, was to admit
The enrollment questionnaire was given at the end of the trial entry interview and consisted of three previously validated scales: the Hospital Anxiety and Depression Scale the anxiety component of a Multiple Affect Adjective Check-List, and a 100 mm linear analog anxiety scale (5–7). Postpartum questionnaire A questionnaire was sent to women 7 weeks after giving birth. The questionnaire addressed satisfaction and experiences with care, current feeding practices (8), and the Edinburgh Postnatal Depression Scale (9). Questions about satisfaction and experiences with care were adapted from a questionnaire (10) based on a previous thematic analysis of 16 interviews with women who had experienced induction of labor (11). Thirty-eight items in the questionnaire were grouped into nine topics. Items were presented as complete statements with a 5-point Likert scale response format. A balance of positively and negatively worded items was included to reduce response bias. Two additional questions addressing concerns about returning to hospital were included for women in the outpatient group. Women (excluding two with an adverse birth outcome) were mailed the questionnaire. Telephone reminders were made after 3 weeks and a further questionnaire was sent if required. Women who scored
77
BIRTH 40:2 June 2013
more than 12 on the Edinburgh Postnatal Depression Scale (12) were reviewed by the research midwife and appropriate referrals made when needed.
Data Analysis We aimed to recruit 400 women per group to detect a reduction in oxytocin augmentation from 50 percent to 40 percent (80% power; a: 0.05). Data were analyzed according to the intention-to-treat principle including all randomized women. A separate analysis was also conducted for women who had received the priming intervention. Mean summated subscales were compared between the two groups with the Student two sample t test, with an F test for equal variances to determine whether homogeneity of variances could be assumed. The Cronbach alpha test was used to examine the internal reliability of the items addressing satisfaction and experiences with care. Statistical analyses were conducted with SPSS version 19.0 (SPSS Inc., Chicago).
Results Participants Of 1,084 women assessed for eligibility, 1,004 were eligible and 827 (82%) consented and were randomized. Four of them were ineligible immediately after randomization and two withdrew from the study, leaving 821 women in the final analysis (407 outpatient, 414 inpatient; Fig. 1). Overall, 51 percent allocated to inpatient and 53 percent allocated to outpatient priming did not receive prostaglandin gel because they had gone into labor or did not require cervical ripening before their scheduled induction. Baseline characteristics were similar in the two groups (Table 1).
Enrollment Questionnaire No difference was found between the two groups for anxiety or depression (Table 2). Women in both groups scored in the normal range (0-7) for anxiety and depres-
Referred for Eligibility N=1,084
n=80 not eligible n=27 spontaneous labor before consented n=150 declined to participate
Enrolled and Randomized n=827
n=416 Randomized Inpatient
n=411 Randomized Outpatient
n=1 ineligible (mistakenly randomized)
n=3 ineligible (mistakenly randomized)
Enrollment questionnaire response rate 99% (409/415)
Enrollment questionnaire response rate 99% (405/408)
n=1 withdrew, no outcome data available
n=1 withdrew permission (partner objected)
n=414 for final analysis
n=407 for final analysis
n=204 Did not require/receive priming intervention: n=195 spontaneous labor, ruptured membranes or cervix favorable n=5 medical complications n=3 declined to have induction n=1 wrong drug given (Cervidil)
n=210 (51%) Received priming gel
n=314 7-week postpartum questionnaire (76% overall response rate, 314/414 mailed)
Fig. 1. Flow of participants.
n=215 (53%) Received priming gel
n=192 Did not require/receive priming intervention: n=186 spontaneous labor, ruptured membranes or cervix favorable n=4 medical complications n=2 declined to have induction
n=306 7-week postpartum questionnaire (76% overall response rate, 306/405 mailed)
BIRTH 40:2 June 2013
78 sion on the Hospital Anxiety Depression Scale. Low anxiety scores were also recorded for both groups on the Multiple Affect Adjective Check-List and the linear analog anxiety scale.
Seven-Week Postpartum Questionnaire The postpartum questionnaire was sent to 819 women after excluding two women who had a poor pregnancy outcome (response rate: 76% in both groups). There were small statistically significant differences between the two groups for seven of the nine subscales with more favorable scores for women allocated to outpatient priming than for those allocated to inpatient primTable 1. Baseline Characteristics of Eligible Women
Characteristic Marital status Married /de facto Single (family supported) Single (unsupported) Language spoken at home English Other language Education Bachelor’s degree or higher Post-high school training High school only Employment Full-time Part-time Casual Not employed
Inpatient (n = 415) No. (%)
Outpatient (n = 408) No. (%)
379 (91) 24 (6) 10 (2)
371 (91) 27 (7) 7 (2)
343 (83) 72 (17)
324 (79) 84 (21)
137 (33) 121 (29) 156 (38)
157 (38) 98 (24) 148 (36)
130 65 37 174
149 54 29 164
(31) (16) (9) (42)
(37) (13) (7) (40)
*Maximum number of not stated for any variable n = 12 (employment).
ing (Table 3). No statistically significant differences were found for the subscales measuring “Environment” and “General Satisfaction.” The direction of effect was preserved with the effect often larger in the subgroup of women who received the intervention. However, no statistically significant differences were found for the subscales of Information and General satisfaction. There were no statistically significant or clinically relevant differences between the two groups for postpartum depression or infant feeding in either the intention-to-treat or treatment-received analyses (Table 4). Two questions specifically addressed potential concerns of women randomized to outpatient priming about making it back to hospital in time or how long to stay at home (Table 5). These analyses were confined to women who received the intervention. Women tended not to be worried about making it back in time and about how long to wait at home.
Discussion This study is the first to systematically compare the psychosocial impact of outpatient and inpatient priming for induction of labor. We analyzed data for all participants, although, in both groups, almost half of them did not need the intervention. Data were also analyzed for those who received the intervention. If outpatient priming is to be offered, it is important that it does not cause women undue anxiety. There is limited research on the acceptability of outpatient priming to women (13–16) and no studies have explored anxiety in women when randomized to inpatient or outpatient priming. Our results show that anxiety scores were low for both inpatient and outpatient women and that outpatient women did not have higher anxiety after being informed that they could go home after cervical priming when compared with inpatient women. An important objective of outpatient priming is to improve maternal satisfaction (2,3). Our findings support the results of previous research on women’s expe-
Table 2. Results of the Enrollment Questionnaire
Findings Hospital Anxiety Depression Scale Anxiety score (scale 0–21) Depression score (scale 0–21) Multiple adjective anxiety checklist 21 words (scale 0–21) Linear analog anxiety scale (scale 0–100 mm)
Inpatients Mean (SD) (n = 5.28 3.12 (n = 6.51 (n = 25.6
409) (3.09) (2.54) 407) (3.54) 405) mm (19.46)
Outpatients Mean (SD) (n = 5.32 3.20 (n = 6.62 (n = 25.7
405) (3.03) (2.66) 404) (3.46) 403) mm (18.91)
Mean difference (95% CI) 0.04 ( 0.46 to 0.38) 0.08 ( 0.43 to 0.27) 0.11 ( 0.59 to 0.37) 0.1 ( 2.75 to 2.55)
79
BIRTH 40:2 June 2013
riences of outpatient priming, which indicated that women were satisfied with the experience (14,15,17). Previous studies have often focused on outpatient
women alone. Only two studies assessed differences in maternal satisfaction between inpatient and outpatient priming (13,16) and they were limited in scope.
Table 3. Results of the Postpartum Questionnaire
Subscales Social support Environment Self-efficacy Readiness Stress Control Information Safety Satisfied
Inpatient N*, mean score (SD)
Outpatient N, mean score (SD)
n = 313 3.92 (0.80) n = 312 4.18 (0.73) n = 312 3.60 (0.84) n = 310 3.00 (0.89) n = 310 3.16 (0.92) n = 311 3.50 (0.80) n = 311 3.63 (0.74) n = 311 3.55 (0.80) n = 202 3.67 (0.88)
n = 305 4.17 (0.66) n = 304 4.24 (0.75) n = 305 3.77 (0.85) n = 304 3.18 (0.97) n = 304 3.37 (0.93) n = 304 3.63 (0.81) n = 304 3.80 (0.76) n = 305 3.72 (0.83) n = 197 3.83 (0.94)
Mean Difference (95% CI) 0.25 ( 0.13 to
0.37)
0.06 ( 0.18 to 0.06) 0.17 ( 0.03 to
0.30)
0.22 ( 0.07 to
0.37)
0.22 ( 0.07 to
0.36)
0.13 ( 0.003 to
0.26)
0.18 ( 0.06 to
0.29)
0.16 ( 0.03 to
0.29)
0.16 ( 0.33 to 0.02)
*Numbers vary with missing data for one or more of the subscale questions. Numbers for the subscale “satisfied” are less overall as many women who did not need an induction ticked the option “not applicable.”
Table 4. Postpartum Depression Scores and Data on Infant Feeding
Findings Edinburgh postnatal Depression scale Score 1 response) Type of infant feeding Fully breastfeeding Mostly* breastfeeding Mixed feeding Mostly* bottle feeding Fully bottle feeding Missing
Inpatients (n = 314)
Outpatients (n = 308)
234 25 20 28 5.81 4 7
(75%) (8%) (6%) (9%) (4.81) (0–26) (2%)
218 28 17 31 5.90 5 12
(71%) (9%) (6%) (10%) (4.53) (0–22) (4%)
182 23 25 8 73 3
(58%) (7%) (8%) (3%) (23%) (1%)
192 24 21 2 63 4
(63%) (8%) (7%) (1%) (20%) (1%)
*Mostly breastfeeding = about 4 out of 5 feedings daily. Mostly bottle feeding = 4 out of 5 feedings daily with bottle.
Table 5. Questionnaire Responses from Women who Received Outpatient Priming (n = 174)
No. (%) “I was worried that I would not make it back to hospital on time” Strongly agree Agree Not sure Disagree Strongly disagree Not applicable* Missing “I was worried about how long I should wait at home” Strongly agree Agree Not sure Disagree Strongly disagree Not applicable* Missing
9 14 8 70 45 27 1
(5) (8) (5) (40) (26) (16) (0.5)
11 34 5 66 27 30 1
(6) (20) (3) (38) (16) (17) (0.5)
*Women’s response to this question. Approximately 20% of women who received outpatient priming gel did not go home because of nonreassuring electronic fetal monitoring or because they changed their mind after receiving the gel.
BIRTH 40:2 June 2013
80 Responses to the postpartum questionnaire showed a small, statistically significant improvement in maternal satisfaction with outpatient priming for almost all aspects of care. There were no statistically significant or clinically relevant differences in Edinburgh Postnatal Depression Scale scores or infant feeding, a finding similar to that of other outpatient approaches which provide less medicalized care (18).
5.
6.
7.
Conclusion
8.
We have presented the psychosocial outcomes of a randomized controlled trial comparing inpatient and outpatient priming for induction of labor. The results indicate that women favored outpatient priming without increasing their anxiety when told they could go home after priming. In the subgroup analysis of women who received the intervention, the direction of the effect was maintained and the size of the effect often enlarged. The option of outpatient care instead of inpatient care appears to confer psychosocial benefit for women needing cervical priming before induction of labor.
9.
10. 11.
12.
13.
14.
Acknowledgments We thank the research midwives, Meredith Kelsey, Narelle de Sciscio, and Helen Pollard, and Philip Ryan, who provided protocol advice.
15.
References
16.
1. Scheil W, Scott J, Catcheside B, Sage L. Pregnancy Outcome in South Australia 2010. Adelaide: Pregnancy Outcome Unit, SA Health, Government of South Australia, 2012. 2. Kelly AJ, Alfirevic Z, Dowswell T. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev 2009; Issue 2, Art No.: CD007372. 3. Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev 2010; Issue 8, Art No.: CD007701. 4. National Collaborating Centre for Women’s and Children’s Health / National Institute for Health and Clinical Excellence
17.
18.
(NCCWCH/NICE). Induction of Labour. London: National Institute for Health and Clinical Excellence (NICE), 2008 Jul. p. 71 (Clinical guideline; no. 70). Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale: an updated literature review. J Psychosom Res 2002;52:69–77. Lubin B, Van Whitlock R, Reddy D, Petren S. A comparison of the short and long forms of the Multiple Affect Adjective Check List-Revised (MAACL-R). J Clin Psychol 2001;57:411–416. Elliott D. Comparison of the three instruments for measuring patient anxiety in a coronary care unit. Intensive Crit Care Nurs 1993;9:195–100. Labbok M, Krasovec K. Toward consistency in breastfeeding definitions. Stud Fam Plann 1990;21:226–230. Affonso DD, Anindya KD, Horowitz JA, Mayberry LJ. An international study exploring levels of postpartum depressive symptomatology. J Psychosom Res 2000;49:207–216. Turnbull D, Holmes A, Shields N, et al. Randomised, controlled trial of efficacy of midwife-managed care. Lancet 1996;348:213–218. Oster C, Adelson PL, Wilkinson C, Turnbull D. Inpatient versus outpatient cervical priming for induction of labour: therapeutic landscapes and women’s preferences. Health Place 2011;17:379– 385. Buist AE, Barnett EW, Milgrom J, et al. To screen or not to screen – that is the question in perinatal depression. Med J Aust 2002;177:S101–S105. Biem SR, Turnell RW, Olatunbosun O, Tauh M, Biem HJ. A randomized controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction. J Obstet Gynaecol Can 2003;25:23–31. Bollapragada SS, MacKenzie F, Norrie JD, et al. Randomised placebo-controlled trial of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour – clinical trial with analyses of efficacy and acceptability. The IMPO Study. BJOG 2009;116:1185–1195. Bullarbo M, Orrskog ME, Andersch B, Granstrom L, Norstrom A, Ekerhovd E. Outpatient vaginal administration of the nitric oxide donor isosorbide mononitrate for cervical ripening and labor induction postterm: a randomized controlled study. Am J Obstet Gynecol 2007;196:50.e1–50.e5. Awartani KA, Turnell RW, Olatunbosun OA. A prospective study of induction of labor with prostaglandin vaginal gel: ambulatory versus in-patient administration. Clin Exp Obstet Gynecol 1999;26:162–165. Reid M, Lorimer K, Norman JE, Bollapragada SS, Norrie J. The home as an appropriate setting for women undertaking cervical ripening before the induction of labour. Midwifery 2011;27: 30–35. Turnbull DA, Wilkinson C, Gerard K, et al. Clinical, psychosocial and economic effects of antenatal day care for three medical complications of pregnancy: a randomised controlled trial of 395 women. Lancet 2004;363:1104–1109.
