Outpatient balloon catheter versus expectant management for post-term labor induction in nulliparous women: A randomized trial.
balloon
cesarean
home induction
mechanical method
term pregnancy
Journal
Journal of gynecology obstetrics and human reproduction
ISSN: 2468-7847
Titre abrégé: J Gynecol Obstet Hum Reprod
Pays: France
ID NLM: 101701588
Informations de publication
Date de publication:
10 Jul 2024
10 Jul 2024
Historique:
received:
14
04
2024
revised:
04
07
2024
accepted:
06
07
2024
medline:
13
7
2024
pubmed:
13
7
2024
entrez:
12
7
2024
Statut:
aheadofprint
Résumé
- Increased use of labor induction has renewed interest in outpatient cervical ripening. Post-term pregnancy (i.e., ≥ 41 weeks) is a specific situation of increased neonatal risk, including greater risk of perinatal death and adverse perinatal outcomes. While a high proportion of these patients will need induction, outpatient management of this specific population has never been studied. Therefore, our objective was to compare two policies of management of post term pregnancies: the use of a transcervical Foley catheter for outpatient cervical ripening compared with expectant management. - Multicenter, randomized controlled open-label study comparing home induction with a Foley catheter versus expectant management. Inclusion criteria were nulliparous, live singleton fetus in a vertex position, post-term (at 41 + 4 days), requiring cervical ripening (Bishop score < 6), intact membranes, and distance home-hospital within 40 minutes. The primary endpoint was change in Bishop score beetween randomization (41 + 4 days) and consultation (41 + 5 days). - Forty-five women were included: 21 in the home induction group and 24 in the control group. The study was stopped due to low recruitment. The difference in Bishop score increases one day after randomization approached significance (p = 0.055), with home induction showing a larger change compared with expectant management (Cohen's d = 0.60; 95% confidence interval [CI] -0.002 to 1.21). Regarding change in Bishop score, 81% of home induction group patients had a better score at 41 + 5 days versus 52.2% in the control group (relative risk = 1.55; 95%CI 0.99 to 2.15). - By specifically evaluating home induction in nulliparous women with post term pregnancies, we observed a Bishop score improvement in the home induction group. These data support further evaluation of induction methods and birth experiences in a larger cohort of this population. The study was registered under European policy (number EudraCT 2015-A01298-41) and on www.clinitrials.gov (number NCT02932319). Date of registration: 13/10/2016, Date of initial participant enrollment: 31/03/2017.
Sections du résumé
BACKGROUND
BACKGROUND
- Increased use of labor induction has renewed interest in outpatient cervical ripening. Post-term pregnancy (i.e., ≥ 41 weeks) is a specific situation of increased neonatal risk, including greater risk of perinatal death and adverse perinatal outcomes. While a high proportion of these patients will need induction, outpatient management of this specific population has never been studied. Therefore, our objective was to compare two policies of management of post term pregnancies: the use of a transcervical Foley catheter for outpatient cervical ripening compared with expectant management.
METHODS
METHODS
- Multicenter, randomized controlled open-label study comparing home induction with a Foley catheter versus expectant management. Inclusion criteria were nulliparous, live singleton fetus in a vertex position, post-term (at 41 + 4 days), requiring cervical ripening (Bishop score < 6), intact membranes, and distance home-hospital within 40 minutes. The primary endpoint was change in Bishop score beetween randomization (41 + 4 days) and consultation (41 + 5 days).
RESULTS
RESULTS
- Forty-five women were included: 21 in the home induction group and 24 in the control group. The study was stopped due to low recruitment. The difference in Bishop score increases one day after randomization approached significance (p = 0.055), with home induction showing a larger change compared with expectant management (Cohen's d = 0.60; 95% confidence interval [CI] -0.002 to 1.21). Regarding change in Bishop score, 81% of home induction group patients had a better score at 41 + 5 days versus 52.2% in the control group (relative risk = 1.55; 95%CI 0.99 to 2.15).
CONCLUSION
CONCLUSIONS
- By specifically evaluating home induction in nulliparous women with post term pregnancies, we observed a Bishop score improvement in the home induction group. These data support further evaluation of induction methods and birth experiences in a larger cohort of this population.
TRIAL REGISTRATION
BACKGROUND
The study was registered under European policy (number EudraCT 2015-A01298-41) and on www.clinitrials.gov (number NCT02932319). Date of registration: 13/10/2016, Date of initial participant enrollment: 31/03/2017.
Identifiants
pubmed: 38997091
pii: S2468-7847(24)00101-6
doi: 10.1016/j.jogoh.2024.102822
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02932319']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
102822Informations de copyright
Copyright © 2024. Published by Elsevier Masson SAS.