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

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

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.

Study Overview

• Status: Completed
• Conditions: DELAYED LABOUR
• Intervention / Treatment: Drug: Oxytocin

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: low dose 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.	Drug: Oxytocin; intravenous infusion
Experimental: high dose 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	Drug: Oxytocin; intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean duration from oxytocin augmentation initiation to delivery	the calculated time between oxytocin infusion till delivery	12 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): October 19, 2021

Study Registration Dates

• First Submitted: July 21, 2018
• First Submitted That Met QC Criteria: July 21, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: OBOX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No