NCT02115256

Brief Summary

Breech presentation of a term pregnancy is a common occurrence. A procedure known as external cephalic version (ECV) is frequently used by obstetricians to turn the baby into the vertex position prior to delivery in order to avoid a cesarean section and the associated risks. Medications to relax the uterus, known as tocolytics, are used in conjunction with the procedure as they have been shown to improve the success rate of ECV, but with inconsistent, varying results.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed
Last Updated

June 14, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

April 13, 2014

Results QC Date

March 31, 2017

Last Update Submit

May 14, 2017

Conditions

External Cephalic Version

Keywords

External Cephalic Versionbreech

Outcome Measures

Primary Outcomes (1)

  • Successful Version of the Fetus Into the Vertex Position

    Number of participants that had successful version of the fetus into the vertex position.

    average of 1 hour

Secondary Outcomes (3)

  • Hypotension

    average of 1 hour

  • Need for Cesarean Delivery

    average of 1 hour

  • Tachycardia

    average of 1 hour

Study Arms (2)

Intravenous Terbutaline

ACTIVE COMPARATOR

0.25 mL of Intravenous Terbutaline

Drug: Intravenous Terbutaline

Intravenous Nitroglycerine

ACTIVE COMPARATOR

IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.

Drug: Intravenous Nitroglycerine

Interventions

Intravenous TerbutalineDRUG

0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.

Also known as: Terbutaline, Brethine, Bricanyl, Brethaire, Terbutalin, (RS)-5-[2-(tert-butylamino)-1-hydroxyethyl]benzene-1,3-diol)
Intravenous Terbutaline
Intravenous NitroglycerineDRUG

The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.

Also known as: Nitroglycerine, Nitroglycerin, Trinitroglycerin, Trinitroglycerine, nitro, 1,2,3-trinitroxypropane
Intravenous Nitroglycerine

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Between 18-35 years of age
  • weeks gestation
  • Breech presentation

You may not qualify if:

  • Patients with ruptured membranes
  • Multiple gestation
  • Maternal age (age \> 35)
  • With known medical comorbidities (including hypertension (HTN), arrhythmias, endocrinologic diseases such as diabetes and thyroid disease, scoliosis, asthma)
  • Allergies to nitroglycerine or terbutaline
  • Prior abdominal or uterine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

TerbutalineNitroglycerin

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesNitro Compounds

Results Point of Contact

Title
Dr. Yaakov Beilin
Organization
Icahn School of Medicine at Mount Sinai
yaakov.beilin@mountsinai.org
212-241-7467

Study Officials

  • Yaakov Beilin, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2014

First Posted

April 16, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 14, 2017

Results First Posted

June 14, 2017

Record last verified: 2017-05

Locations

US(1)