Continuous Oxytocin Infusion Versus Pulsatile Intravenous Oxytocin for Augmentation of First Stage of Labor

NCT02723461 | Unknown Phase 4 DMC

• 1 other identifier: pulsatile oxytocin
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing continuous intravenous oxytocin infusion with pulsatile administration of intravenous oxytocin for augmentation of the first stage of labor.

Conditions

Failed Induction (of Labor) by Oxytocin

Outcome Measures

Primary Outcomes (1)

• duration of active phase of first stage of labor

  The time in hours from start of infusion of pulsatile oxytocin at onset of established labor (cervical dilatation 3-4 cm ) to the end of first stage of labour (cervical dilatation 10 cm)

  24 hours

Study Arms (2)

pulsatile oxytocin

ACTIVE COMPARATOR

Using a programmable syringe pump, the pulsatile regime, oxytocin (Syntocinon, stock solution: 10 iU/mL) will be administered for 10 seconds every 6 minutes and the dose (2 mU/pulse) doubled every 30 minutes until uterine contractions will be established (3-4 in 10 minutes). This regime stems from the observation that physiologic oxytocin may be released in a pulsatile fashion every 4-6 minutes (Dawood et al.,1979)

Drug: Pulsatile Oxytocin

continuous oxytocin

ACTIVE COMPARATOR

Continuous group will be administrated oxytocin (Syntocinon, stock solution: 10 iU/mL) at starting dose (2 mU/min) in a continuous manner doubled every 30 minutes until uterine contractions will be established (3-4 in 10 minutes).

Drug: Continuous Oxytocin

Interventions

Pulsatile Oxytocin DRUG

Using a programmable syringe pump, oxytocin will be administered for 10 seconds every 6 minutes and the dose (2 mU/pulse) doubled every 30 minutes until uterine contractions will be established (3-4 in 10 minutes).

Also known as: syntocinon

pulsatile oxytocin

Continuous Oxytocin DRUG

Oxytocin will be administered at starting dose (2 mU/min) in a continuous manner doubled every 30 minutes until uterine contractions will be established (3-4 in 10 minutes).

Also known as: syntocinon

continuous oxytocin

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women in labor (cervical dilatation 3-4 centimeters) who require augmentation of first stage of labor.
• Single viable fetus.
• Rupture of membranes before augmentation of labor.
• Cephalic presentation.
• Term pregnancy.

You may not qualify if:

• Malpresentation.
• Induction of labor by prostaglandins.
• Any uterine previous surgery.
• Fetal anomalies.
• Premature labor.
• Previous cesarean section.
• Any uterine anomalies.
• Multiple pregnancy.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams maternity hospital

Cairo, Egypt

RECRUITING

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

Central Study Contacts

Amr A Riad, MD

CONTACT

01005347179; amr.riad@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: March 26, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

EG (1)