Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Tours

About this trial

Twenty-two percent of deliveries in France are induced. In cases where labor is induced and cervix is unfavorable, cervical ripening prior oxytocin administration is advised in order to reduce the risk of cesarean delivery. Cervical ripening agents, pharmacological (prostaglandins) or mechanical are administered during 24 hours. After 24 hours, most women will be either delivered or in labor but 25% of women will require further induction of labor. For 16% of women who undergo cervical ripening, whatever the cervical ripening method, the cervix remains unchanged after 24 hours. The management of these women is not consensual and depends on the maternity unit where women are cared for.

This study seeks to identify the most appropriate strategy for the management of women with an unfavorable cervix after 24 hours of cervical ripening, a strategy which would be associated with the lowest maternal and perinatal morbidity but also with the best maternal satisfaction. Because both strategies are practiced in France, the trial would compare: induction of labor with oxytocin and repeated cervical ripening. The aim is to show that repeating cervical ripening is an unnecessary procedure. And more specifically that oxytocin administration is not associated with a higher caesarean delivery rate and that it reduces the time to delivery in comparison with cervical ripening with prostaglandins.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant woman

≥ 18 years old

With a singleton cephalic pregnancy

≥37+0 weeks of gestation

Disqualifiers

Any measures of legal protection

Prior caesarean section or uterine scar

Contra-indications to a vaginal delivery

Foetus with suspected severe congenital abnormalities

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prostaglandins

    Drug

    Second cervical ripening lasting a maximum of 24 hours

  • Oxytocin

    Drug

    Induction of labor with oxytocin.

Treatment groups

1,494 Participants
are divided into 2 treatment groups
Group A: Induction of laborExperimental treatment 1 intervention
Group B: Second cervical ripeningActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Cesarean delivery rate

The main outcome is the rate of caesarean delivery, whatever the indication of the caesarean delivery

Time frame
Up to 2 days after intervention

Secondary outcomes

1

Time from intervention to delivery in hours

Time frame
Up to 2 days after intervention
2

The proportion of women who delivered within 12 hours of the intervention

Time frame
Up to 12 hours after intervention
3

Maternal satisfaction, assessed with the self administered ACE Questionnaire for Assessing Childbirth Experience (QACE)

Time frame
1 month
4

The proportion of women who require induction with oxytocin (for women in the control group)

Time frame
Up to 2 days after intervention

Other outcomes

1

Number and rate of children with an Apgar score under 7

Time frame
Up to 2 days after intervention
2

Number and rate of children with neonatal acidosis defined as umbilical arterial pH <7,00

Time frame
Up to 2 days after intervention
3

Number and rate of children with early neonatal infection

Time frame
Up to 7 days after delivery
4

Number and rate of children admitted in an intensive care unit

Time frame
Up to 7 days after delivery

Sponsors and contacts

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