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

NCT03604874 | Completed Phase 4

• 1 other identifier: OBOX
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

DELAYED LABOUR

Outcome Measures

Primary Outcomes (1)

• The mean duration from oxytocin augmentation initiation to delivery

  the calculated time between oxytocin infusion till delivery

  12 hours

Study Arms (2)

low dose oxytocin

ACTIVE COMPARATOR

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

high dose oxytocin

EXPERIMENTAL

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

Interventions

Oxytocin DRUG

intravenous infusion

high dose oxytocin; low dose oxytocin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: July 30, 2018
• Study Start: September 1, 2018
• Primary Completion: August 31, 2020
• Study Completion: October 19, 2021
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)