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Completed

NCT Number: NCT04514770

Impact of Early Versus Late Amniotomy on Labour Induction in Nulliparous Women After Vaginal Misoprostol

Investigation the effect of timing of amniotomy (early versus delayed) after vaginal misoprostol in induced labor.

Condition: induction of labour intervention: eary versus late amniotomy on labour induction after vaginal misoprostol Phase: Not applicable

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Key information

Conditions

Labour Induction

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University hospital

Shibīn al Kawm, Menoufia, 11111, Egypt

About this study

study type: randomized clinical trial actual enrollment: 140 allocation: Random intervention model: two groups assignment masking: open lebal primary purpose: induction of labour actual study start: May 3, 2019 Primary Completion: January 10, 2020 actual study completion date: March 20, 2020

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant women at 36 weeks gestation or more
  • Nullipara
  • singleton fetus
  • cephalic presentation with common medical causes for labour induction e.g. intrauterine fetal growth restriction, post term pregnancy and preeclampsia.

Exclusion criteria

  • Macrocosmic babies with estimated fetal weight of more than 4000 gram
  • Previous uterine scars
  • Pre labor premature rupture of fetal membranes
  • Polyhydramnios.

Treatment and study plan

Misoprostol

Drug

rupture of membrane early and late

Other names: Amniotomy

Primary outcomes

  1. successful induction

    Time frame: immediately after intervention

    definition of successful induction is occurrence of vaginal delivery within 24 hours from the beginning of induction

  2. induction-delivery interval

    Time frame: immediately after intervention

    duration of labor and amniotomy delivery interval

Secondary outcomes

  1. misoprostol doses administered

    Time frame: during the intervention

    number of misoprostol doses administered

  2. the need for augmentation of labor

    Time frame: during the intervention

    the need for augmentation of labor by oxytocin and perinatal outcomes included cord prolapse and abnormal FHR changes during labor

  3. intrapartum meconium

    Time frame: during the intervention

    intrapartum meconium passage

  4. Apgar score

    Time frame: during the intervention

    Apgar score less than 7 at 1 and 5 minutes

  5. newborn admission in the neonatal intensive care unit

    Time frame: immediately after intervention

    newborn admission in the neonatal intensive care unit (NICU).

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Early Versus Late Amniotomy on Labour Induction in Nulliparous Women

Acronym: RCT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2020
Registry last updated
Aug 17, 2020

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.

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