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NCT01113229·Phase 4·INTERVENTIONAL

Combined Use of Oxytocin and Misoprostol in the Prevention of Post Partum Haemorrhage

OxytocinOtherTerminated

Status

Terminated

Phase

Phase 4

Enrollment

1,721

Locations

1

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.

Full detailed description

Objective : To demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks'. Method : Double blinded Randomized controlled trial in two centers over 30 months. Treatment : Patients will be randomly allocated into one of the two following group : Group A : 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp. Group B: 10 UI of oxytocin IV during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp. Number of patients: 1550 patients per group (one third reduction of occurrence with alpha and beta set at 0.05 and 0.20 respectively). Patients were included in the study during 48 hours.

Interventions

Treatment arms and agents.

DRUG

Misoprostol

two misoprostol tablets taken orally (400µg)

Timeline

From registration to results.

  1. First posted

    Apr 29, 2010

  2. Study start

    Mar 2010

  3. Primary completion

    Jul 2014

  4. Study completion

    Dec 2014

  5. Results posted

    Not reported

  6. Registry updated

    Mar 27, 2026

Outcomes

What the study measures.

Primary outcomes

Occurrence of post partum hemorrhage > 500mL in 1 hour

Time frame · 1 HOUR

Secondary outcomes

Occurrence of post partum hemorrhage > 1000mL in 1 hour

Time frame · 1 HOUR

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * Women\>18 years, * during first stage of normal labor, * at 36 to 42 weeks, * with epidural analgesia and informed signed consent Exclusion Criteria: * Cesarean section delivery, * clotting disorders, * prostaglandin allergy, * absent consent.

Study locations

1 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

Chi Poissy St Germain

Poissy, France

Publications

Results and literature.

PMID 27607864 ↗Quibel T, Ghout I, Goffinet F, Salomon LJ, Fort J, Javoise S, Bussieres L, Aegerter P, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Active Management of the Third Stage of Labor With a Combination of Oxytocin and Misoprostol to Prevent Postpartum Hemorrhage: A Randomized Controlled Trial. Obstet Gynecol. 2016 Oct;128(4):805-11. doi: 10.1097/AOG.0000000000001626.PMID 39934771 ↗Voillequin S, Quibel T, Rozenberg P, Rousseau A. Duration of the second and third stages of labor and risk of postpartum hemorrhage: a cohort study stratified by parity. BMC Pregnancy Childbirth. 2025 Feb 11;25(1):143. doi: 10.1186/s12884-025-07229-4.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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