Early Amniotomy After Vaginal Prostaglandin E2 for Induction of Labor at Term: a Randomized Clinical Trial (PGE2)

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status and phase: Completed; Phase 2

Conditions: Early Amniotomy, Unfavorable Cervix

Treatments: Drug: PGE2

Study type: Interventional

Funder types: Other

Identifiers

NCT02856724

145

Details and patient eligibility

About

This study evaluates the effectiveness and safety of early amniotomy after vaginal prostaglandin E2 for induction of labor at term. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will dilated 3 cm using the amniotomy hook. Amniotomy will not be done for control group(other half of participants) until the membranes rupture spontaneously.

Full description

During induction of labour, amniotomy (defined as artificial rupture of fetal membranes) is commonly used in combination with induction of labor. However, there is a lack of data on both effectiveness and ideal timing of this procedure. Yet for patients with an unfavorable cervix, a sharply ripening agent may be considered. As is well known to all,prostaglandin works efficiently in cervical ripening and labor induction. So dinoprostone surely performs quite well in promoting cervical ripening and labor induction since its main component is prostaglandin E2 (PGE2).

Enrollment: 200 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. singleton pregnancy,
2. gestational age ≥34 weeks,
3. intact membranes,
4. cephalic presentation,
5. bishop score ≤5,
6. had obstetrical indications for induction of labor,
7. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria:

1. Patients who have contraindications for vaginal delivery,
2. previous uterine surgery,
3. fetal malpresentation,
4. multifetal pregnancy,
5. more than three contractions in 10 minutes,
6. contraindications to prostaglandins,
7. a category II or III fetal heart rate pattern,
8. anomalous fetus,
9. fetal demise
10. women with immediate delivery indications -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Early amniotomy and PGE2

Experimental group

Description:

10 mg PGE2 vaginal ovul(Propess) Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.

Treatment:

Drug: PGE2

PGE2

Active Comparator group

Description:

10 mg PGE2 vaginal ovul(Propess)

Treatment:

Drug: PGE2