Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension

NCT ID: NCT02265965

Last Updated: 2020-05-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-07-01

Brief Summary

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Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second stage arrest of descent to prevent or uterine extension at the hysterectomy site.

Detailed Description

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Intravenous nitroglycerin resulting in uterine relaxation has been standardly utilized for various obstetrics conditions, e.g. breech extraction of second twin in vaginal deliveries, uterine relaxation after tachysystole in labor, prior to external cephalic version, and during difficult fetal extraction during cesarean delivery for arrest of descent in labor. Currently the use of nitroglycerin is at equipoise in obstetrics for difficult cesarean delivery after second stage arrest in labor. The clinical trial will randomize women who undergo cesarean delivery for second stage arrest in labor to receive IV nitroglycerin vs saline at the time of hysterotomy. The primary outcomes will be maternal: uterine extension, blood loss, total fetal extraction time, surgical time; neonatal: cord gases at delivery, apgar scores, admission to neonatal intensive care unit.

Conditions

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Prolonged Second Stage of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Intravenous Nitroglycerin

Subjects will receive IV nitroglycerin at the time of Hysterotomy. Infusion will be stopped once neonate is delivered

Group Type EXPERIMENTAL

intravenous nitroglycerin

Intervention Type DRUG

Infusion at started at time of hysterotomy and stopped at neonate delivery

Intravenous Saline

Subjects will receive IV saline at the time of Hysterotomy. Infusion will be stopped once neonate is delivered

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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intravenous nitroglycerin

Infusion at started at time of hysterotomy and stopped at neonate delivery

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer M Lucero, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University California San Francisco-Labor and Delivery

San Francisco, California, United States

Site Status

Countries

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United States

References

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Isquick S, Henry D, Nakagawa S, Moghadassi M, Thiet MP, Norton M, Lucero J. The association between nitroglycerin use and adverse outcomes in women undergoing cesarean delivery in the second stage of labor. J Matern Fetal Neonatal Med. 2017 Jun;30(11):1297-1301. doi: 10.1080/14767058.2016.1212010. Epub 2016 Aug 2.

Reference Type RESULT
PMID: 27405400 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UCSF-OB-NTG

Identifier Type: -

Identifier Source: org_study_id

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