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

Phase 4

Completed

• Conditions: DELAYED LABOUR
• Interventions: Drug: Oxytocin

• Registration Number: NCT03604874
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-21
• Study First Submitted QC: 2018-07-21
• Study First Posted: 2018-07-30
• Study Start: 2018-09-01
• Primary Completion: 2020-08-31
• Study Completion: 2021-10-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 202

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose oxytocin	Oxytocin	patients will receive intravenous infusion of 5 Units of oxytocin/500 mL lactated ringer solution. Starting rate will be 2 mU/min, incrementally increase by 2 mU/min every 30 minutes until achievement of adequate uterine contractions.
high dose oxytocin	Oxytocin	patients will receive intravenous infusion of 5 Units of oxytocin/500 mL lactated ringer solution. Starting rate will be 4 mU/min, incrementally increase by 4 mU/min every 30 minutes until achievement of adequate uterine contractions

Primary Outcome Measures

Name	Time	Method
The mean duration from oxytocin augmentation initiation to delivery	12 hours	the calculated time between oxytocin infusion till delivery

Trial Locations

Locations (1)

Assiut Faculty of Medicine; 🇪🇬 Assiut, Egypt