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

Assiut University

Status and phase: Completed; Phase 4

Conditions: DELAYED LABOUR

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT03604874

OBOX

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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202 participants in 2 patient groups

low dose oxytocin

Active Comparator group

Description:

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.

Treatment:

Drug: Oxytocin

high dose oxytocin

Experimental group

Description:

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

Treatment:

Drug: Oxytocin