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

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ClinicalTrials.gov Identifier: NCT02723461
Recruitment Status : Unknown
Verified September 2016 by Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
First Posted : March 30, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital

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

Condition or disease Intervention/treatment Phase
Failed Induction (of Labor) by Oxytocin Drug: Pulsatile Oxytocin Drug: Continuous Oxytocin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial Comparing Continuous Intravenous Oxytocin Infusion With Pulsatile Administration of Intravenous Oxytocin for Augmentation of the First Stage of Labor
Study Start Date : March 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: pulsatile oxytocin
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
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).
Other Name: syntocinon

Active Comparator: continuous oxytocin
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
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).
Other Name: syntocinon




Primary Outcome Measures :
  1. duration of active phase of first stage of labor [ Time Frame: 24 hours ]
    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)



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Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

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

Exclusion Criteria:

  1. Malpresentation.
  2. Induction of labor by prostaglandins.
  3. Any uterine previous surgery.
  4. Fetal anomalies.
  5. Premature labor.
  6. Previous cesarean section.
  7. Any uterine anomalies.
  8. Multiple pregnancy.

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): NCT02723461


Contacts
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Contact: Amr A Riad, MD 01005347179 ext +2 amr.riad@med.asu.edu.eg

Locations
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Egypt
Ain Shams maternity hospital Recruiting
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital

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Responsible Party: Amr Ahmed Mahmoud Riad, Lecturer of obstetrics and gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02723461     History of Changes
Other Study ID Numbers: pulsatile oxytocin
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs