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OpenTrials
Completed

NCT Number: NCT03604874

High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women

Obesity is one of the biggest public health problems of the 21st century as it increases the risk of many co-morbid medical conditions. Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and puerperium. Obesity is a risk factor for cesarean delivery, failed induction of labor and labor dystocia, and prolonged labor curves especially among women with class III obesity.

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Key information

Conditions

DELAYED LABOUR

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assiut Faculty of Medicine

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Spontaneous onset of labor.
  • Body mass index ≥ 30 kg/m2.
  • Gestational age ≥ 37 weeks.
  • Singleton pregnancy.
  • Cephalic presentation.
  • Reassuring fetal heart rate monitoring.
  • Inefficient uterine contractions during active labor
  • Women who will accept to participate in the study.

Exclusion criteria

  • Non-reassuring fetal assessment at the time of recruitment.
  • Women received cervical ripening agents.
  • Any patients contraindicated for vaginal delivery.
  • Multiple gestations.
  • Malpresentation.
  • Previous cesarean delivery.
  • Patients with cardiac diseases, pre-eclampsia or any other medical disorders.
  • Fetal demise.
  • Intrauterine growth restriction.
  • Estimated fetal weight ≥ 5000 grams.
  • Pre-labor rupture of membranes > 24 hours.

Treatment and study plan

Oxytocin

Drug

intravenous infusion

Primary outcomes

  1. The mean duration from oxytocin augmentation initiation to delivery

    Time frame: 12 hours

    the calculated time between oxytocin infusion till delivery

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women: A Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 30, 2018
Registry last updated
May 9, 2022

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.