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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03604874
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Study Description
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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.

Condition or disease Intervention/treatment Phase
DELAYED LABOUR Drug: Oxytocin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women: A Randomized Clinical Trial
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The mean duration from oxytocin augmentation initiation to delivery [ Time Frame: 12 hours ]
    the calculated time between oxytocin infusion till delivery


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604874


Locations
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Egypt
Assiut Faculty of Medicine Recruiting
Assiut, Egypt
Contact: Ahmed Abbas, MD    00201003385183    bmr90@hotmail.com   
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03604874    
Other Study ID Numbers: OBOX
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs