Induction of labor with Foley catheter and risk of subsequent preterm birth: follow‐up study of two randomized controlled trials (PROBAAT‐1 and ‐2)

Induction of labor with Foley catheter and risk of subsequent preterm birth: follow‐up study of two randomized controlled trials (PROBAAT‐1 and ‐2)

ABSTRACT Objective To evaluate the rate of preterm birth (PTB) in a subsequent pregnancy in women who had undergone term induction using a Foley catheter compared with prostaglandins. Methods This was a follow‐up study of two large randomized controlled trials (PROBAAT‐1 and PROBAAT‐2). In the origi...

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Bibliographic Details
Published in:Ultrasound in obstetrics & gynecology Vol. 57; no. 2; pp. 292 - 297
Main Authors: Vaan, M. D. T., Blel, D., Bloemenkamp, K. W. M., Jozwiak, M., Eikelder, M. L. G., Leeuw, J. W., Oudijk, M. A., Bakker, J. J. H., Rijnders, R. J. P., Papatsonis, D. N., Woiski, M., Mol, B. W., Heus, R.
Format: Journal Article
Language:English
Published: Chichester, UK John Wiley & Sons, Ltd 01-02-2021
Wiley Subscription Services, Inc
Subjects:
balloon
Birth
Catheters
Catheters - adverse effects
cervical ripening
Childbirth & labor
Clinical trials
Female
Fetuses
Foley catheter
Follow-Up Studies
Gestation
Gynecology
Humans
Induced labor
induction of labor
Labor
Labor, Induced
Medical instruments
Misoprostol
Netherlands
Obstetrics
Original Paper
Original Papers
Pregnancy
Premature birth
Premature Birth - etiology
preterm birth
Prostaglandin E2
Prostaglandins
Randomized Controlled Trials as Topic
Risk
Risk Factors
Ultrasonic imaging
Ultrasound
Urinary Catheterization - adverse effects
Vagina
Netherlands
cervical ripening
preterm birth
balloon
induction of labor
Foley catheter
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Summary:ABSTRACT Objective To evaluate the rate of preterm birth (PTB) in a subsequent pregnancy in women who had undergone term induction using a Foley catheter compared with prostaglandins. Methods This was a follow‐up study of two large randomized controlled trials (PROBAAT‐1 and PROBAAT‐2). In the original trials, women with a term singleton pregnancy with the fetus in cephalic presentation and with an indication for labor induction were randomized to receive either a 30‐mL Foley catheter or prostaglandins (vaginal prostaglandin E2 in PROBAAT‐1 and oral misoprostol in PROBAAT‐2). Data on subsequent ongoing pregnancies > 16 weeks’ gestation were collected from hospital charts from clinics participating in this follow‐up study. The main outcome measure was preterm birth < 37 weeks’ gestation in a subsequent pregnancy. Results Fourteen hospitals agreed to participate in this follow‐up study. Of the 1142 eligible women, 572 had been allocated to induction of labor using a Foley catheter and 570 to induction of labor using prostaglandins. Of these, 162 (14%) were lost to follow‐up. In total, 251 and 258 women had a known subsequent pregnancy > 16 weeks' gestation in the Foley catheter and prostaglandin groups, respectively. There were no differences in baseline characteristics between the groups. The overall rate of PTB in a subsequent pregnancy was 9/251 (3.6%) in the Foley catheter group vs 10/258 (3.9%) in the prostaglandin group (relative risk (RR), 0.93; 95% CI, 0.38–2.24), and the rate of spontaneous PTB was 5/251 (2.0%) vs 5/258 (1.9%) (RR, 1.03; 95% CI, 0.30–3.51). Conclusion In women with term singleton pregnancy, induction of labor using a 30‐mL Foley catheter is not associated with an increased risk of PTB in a subsequent pregnancy, as compared to induction of labor using prostaglandins. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
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ISSN:0960-7692
1469-0705
DOI:10.1002/uog.23117