NCT02856724

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

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

• Early Amniotomy, Unfavorable Cervix

Interventions

Type	Name	Description
DRUG	PGE2	10 mg PGE2 vaginal ovul(Propess)

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-08-05
• Last updated: 2016-12-08

Locations

1 site across 1 country: Turkey (Türkiye)