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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02410655
Other study ID # 16-00279
Secondary ID
Status Withdrawn
Phase Phase 4
First received April 2, 2015
Last updated July 27, 2017
Start date November 2015
Est. completion date July 27, 2017

Study information

Verified date July 2017
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.


Description:

A traditional practice in many US hospitals includes use of 10-40 IU of Oxytocin mixed in various volumes of crystalloid administered at an unspecified and uncontrolled rate (quite often off the pump) in order to restore uterine tone and minimize routine blood loss in the third stage of labor. Many practitioners question high dose oxytocin regimens, timing and duration of Oxytocin administration for postpartum hemorrhage prophylaxis. Given the lack of a universally accepted, evidence based protocol, this study aims at comparing the efficacy of a traditional approach of administration of Oxytocin with an evidence-based designed algorithm.


Other known NCT identifiers
  • NCT02453568

Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 27, 2017
Est. primary completion date July 27, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Vaginal Delivery

Exclusion Criteria:

- Cesarean Delivery

- Allergy to Oxytocin

- Cardiac Arrhythmia

Study Design


Intervention

Drug:
Oxytocin
500 mL bag of oxytocin (30 IU / 500 mL) to be connected to the IV, and controlled at the obstetricians request. Up to two, 50 mL rapid infusion boluses to be given after delivery of anterior shoulder. Upon completing the bolus(es) flow rate should be continued at 100 mL / hour. This should total no more than 4.5 hours.
Oxytocin
A total of two 1000 mL bags of oxytocin (20 IU/ 1000 mL) are to be connected to the IV sequentially, and controlled at the obstetricians request, are each to be administered over 8 hours after delivery of anterior shoulder in vaginal delivery. This will total 16 hours of oxytocin infusion.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
New York University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary Estimated blood loss 24 hours postpartum
See also
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Not yet recruiting NCT02319707 - Management of the Third Stage of Labor Phase 3
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Completed NCT02079558 - Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section Phase 2
Withdrawn NCT01108302 - Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India N/A
Completed NCT00097123 - RCT of Misoprostol for Postpartum Hemorrhage in India N/A
Completed NCT02883673 - Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage N/A
Completed NCT02542813 - Safety, Tolerability and Pharmacokinetics (PK) Study of Oxytocin (GR121619) Administered Via an Inhaled Route in Healthy Female Volunteers Phase 1
Completed NCT04201665 - EMG for Uterotonic Efficiency Estimation N/A
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Not yet recruiting NCT05501106 - Reducing Postpartum Hemorrhage After Vaginal Delivery N/A
Completed NCT05429580 - Prophylactic Tranexamic Acid Use After Vaginal Delivery N/A
Terminated NCT03064152 - Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery N/A
Recruiting NCT05382403 - Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage N/A
Completed NCT02805426 - Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage Phase 4
Not yet recruiting NCT02853552 - Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding Phase 4
Completed NCT03344302 - Oxytocin Administration During Cesarean Section Phase 4