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Completed

NCT Number: NCT02856724

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

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.

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Key information

Conditions

Early Amniotomy, Unfavorable Cervix

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Zeynep Kamil Woman and Child Diseases Education and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

PGE2

Drug

10 mg PGE2 vaginal ovul(Propess)

Other names: dinoprostone

Primary outcomes

  1. induction-to- delivery time

    Time frame: delivery (the length of time between the beginning of induction and the end of labor)

Secondary outcomes

  1. mode of labor (vaginal or C-section)

    Time frame: delivery

  2. successful induction

    Time frame: vaginal delivery within 24 h from the beginning of induction

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Acronym: PGE2

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 5, 2016
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.