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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Conditions
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Early Amniotomy, Unfavorable Cervix

Intervention / Treatment
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* Drug: PGE2


Participation Criteria
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Eligibility Criteria
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Inclusion criteria singleton pregnancy, gestational age ≥34 weeks, intact membranes, cephalic presentation, bishop score ≤5, had obstetrical indications for induction of labor, had less than three uterine contractions in every 10 minutes. Exclusion Criteria: Patients who have contraindications for vaginal delivery, previous uterine surgery, fetal malpresentation, multifetal pregnancy, more than three contractions in 10 minutes, contraindications to prostaglandins, a category II or III fetal heart rate pattern, anomalous fetus, fetal demise women with immediate delivery indications -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early amniotomy and PGE2<br>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. | Drug: PGE2<br>* 10 mg PGE2 vaginal ovul(Propess)<br>* Other names: dinoprostone;|
| Active Comparator: PGE2<br>10 mg PGE2 vaginal ovul(Propess) | Drug: PGE2<br>* 10 mg PGE2 vaginal ovul(Propess)<br>* Other names: dinoprostone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction-to- delivery time |  | delivery (the length of time between the beginning of induction and the end of labor) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mode of labor (vaginal or C-section) |  | delivery | 
| successful induction |  | vaginal delivery within 24 h from the beginning of induction |