Oxytocin Dosage to Decrease Induction Duration

NCT03140488 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1702231223
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial in which women are allocated either 'high dose' or 'low dose' oxytocin infusions for induction of labour. The randomization is stratified by maternal body mass index.

Conditions

Obesity; Labor, Induced; Oxytocin

Keywords

Induction of labor; Pitocin; BMI

Outcome Measures

Primary Outcomes (1)

• Length of Time to Delivery

  Number of minutes from induction of labor with oxytocin infusion to delivery of infant, no maximum amount of time specified.

  Start of induction to Delivery

Secondary Outcomes (6)

• Maximum Oxytocin Infusion Rate

  Start of induction to Delivery

• Number of Participants With Terbutaline Use

  Start of induction to Delivery

• Rate of Cesarean Delivery

  Start of induction to Delivery

• Rate of Cesarean Delivery for Labor Arrest

  Start of induction to Delivery

• Maternal Blood Loss

  At delivery

Study Arms (4)

Lean-Control

ACTIVE COMPARATOR

1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.

Drug: Oxytocin

Lean-Intervention

EXPERIMENTAL

2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.

Drug: Oxytocin

Obese-Control

ACTIVE COMPARATOR

3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.

Drug: Oxytocin

Obese-Intervention

EXPERIMENTAL

4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.

Drug: Oxytocin

Interventions

Oxytocin DRUG

Patients will be randomized to low dose or high dose oxytocin for induction of labor.

Also known as: Pitocin, Syntocinon

Lean-Control; Lean-Intervention; Obese-Control; Obese-Intervention

Eligibility Criteria

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

You may qualify if:

• Singleton pregnancy ≥ 37 weeks gestation
• Patient presented for induction of labor who is determined to be a candidate for oxytocin
• Cephalic presentation
• Reassuring fetal health assessment (no abnormal findings in fetal assessment, see below)
• Meeting one of the following BMI category:
• Obese group: BMI ≥30 at \<20 weeks of pregnancy, or BMI ≥35 at a term gestation of pregnancy Lean group: BMI ≤25 at \<20 weeks of pregnancy, or BMI ≤28 at a term gestation of pregnancy

You may not qualify if:

• Non-reassuring fetal assessment at the time of recruitment
• Previous cervical ripening agents (cytotec, cervidil, cervical Foley Balloon)
• \<18 years of age
• Prisoners
• Any patients contraindicated for vaginal delivery
• Multiple gestations
• History of previous cesarean delivery
• Patients with history of significant cardiac disease
• Fetal demise
• Estimated fetal weight greater than 4500 grams in diabetic and 5000 grams in non-diabetic mother
• Ruptured membranes
• Spontaneous labor (latent or active phase)
• Augmentation of labor (latent or active phase)

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Tucson

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• Wei RM, Bounthavong M, Hill MG. High- vs low-dose oxytocin in lean and obese women: a double-blinded randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jul;4(4):100627. doi: 10.1016/j.ajogmf.2022.100627. Epub 2022 Mar 28.

  PMID: 35358738 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Meghan Hill
• Organization: University of Arizona

meghan.hill@auckland.ac.nz

+64273095220

Study Officials

• Meghan Hill, MBBS

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This portion of the study will be carried out by the research pharmacy. Single (low dose) and triple (high dose) concentration of oxytocin will be premixed in the intravenous fluid bag in the pharmacy. Sequence generation for randomization will be created with 1:1 ratio in both the obese and lean group by the Department of Statistics. After the sequence is generated, ths list will be given to the research pharmacy. The premixed oxytocin medication will be sequentially labelled as "OPS drug, patient #1, 2, 3" etc. per the allocation. Allocation concealment will also be carried out by pharmacy as these bags will completely appear identical after they are labelled numerically. Once a patient is randomized, the pharmacy will send up the appropriate concentration of oxytocin already premixed in the intravenous fluid bag, labelled as "OPS drug, patient #". Lean group will be assigned at # 1-70 and obese group will be assigned at #71-140.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 4 Comparison groups: 1. Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol 2. Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol 3. Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol 4. Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 4, 2017
• Study Start: June 5, 2017
• Primary Completion: October 12, 2018
• Study Completion: September 5, 2019
• Last Updated: December 20, 2022
• Results First Posted: December 20, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)