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Balloon + Oxytocin versus Oral Misoprostol to Induce labor in case of premature rupture of membranes (PROM) at term in nulliparous

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501142-30-00
Acronym
PHRC N 2020 GALLOT
Enrollment
520
Registered
2022-09-15
Start date
2023-01-17
Completion date
2025-08-29
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pregnant women with premature rupture of membranes

Brief summary

Proportion of patients vaginally delivered <24h (binary endpoint Yes/No), Satisfaction of women concerning method of induction assessed between the second day after delivery (D2) and hospital discharge by the EXperience of Induction Tool (EXIT) validated in french language. Total score is not relevant29. So, three dimensions are explored and analyzed by EXIT scale: time taken to give birth, discomfort with IOL, experience of subsequent contractions.

Detailed description

Duration from rupture to beginning of induction, Duration between IOL and delivery, Duration of balloon exposure or misoprostol exposure, Total dose of misoprostol received, Bishop score on balloon removal, Rate of balloon in place at H12, Duration until full cervical dilatation, Rate of spontaneous vaginal delivery or instrumental delivery, Indication and rate of cesarean section, Rate of post-partum hemorrhage, Rate of fever during labour, Rate of patients experiencing episode(s) of uterine hyperstimulation during labour, Rate of endometritis, Duration of hospital stay, Birth weight, Apgar < 7 at 5 min (binary endpoint Yes/No), pH umbilical artery, Base defect and lactate (umbilical artery), at birth, Rate of transfer to intensive care unit or neonatology unit, Rate of maternal-fetal infection, Age at hospital discharge

Interventions

DRUGOXYTOCIN
DRUGCLINDAMYCIN
DRUGAMOXICILLIN
DRUGMISOPROSTOL

Sponsors

CHU Gabriel-Montpied
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Proportion of patients vaginally delivered <24h (binary endpoint Yes/No), Satisfaction of women concerning method of induction assessed between the second day after delivery (D2) and hospital discharge by the EXperience of Induction Tool (EXIT) validated in french language. Total score is not relevant29. So, three dimensions are explored and analyzed by EXIT scale: time taken to give birth, discomfort with IOL, experience of subsequent contractions.

Secondary

MeasureTime frame
Duration from rupture to beginning of induction, Duration between IOL and delivery, Duration of balloon exposure or misoprostol exposure, Total dose of misoprostol received, Bishop score on balloon removal, Rate of balloon in place at H12, Duration until full cervical dilatation, Rate of spontaneous vaginal delivery or instrumental delivery, Indication and rate of cesarean section, Rate of post-partum hemorrhage, Rate of fever during labour, Rate of patients experiencing episode(s) of uterine hyperstimulation during labour, Rate of endometritis, Duration of hospital stay, Birth weight, Apgar < 7 at 5 min (binary endpoint Yes/No), pH umbilical artery, Base defect and lactate (umbilical artery), at birth, Rate of transfer to intensive care unit or neonatology unit, Rate of maternal-fetal infection, Age at hospital discharge

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026