NCT02265965

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 22, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 19, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

2.8 years

First QC Date

September 22, 2014

Results QC Date

April 14, 2020

Last Update Submit

May 6, 2020

Conditions

Prolonged Second Stage of Labor

Outcome Measures

Primary Outcomes (5)

  • Number of Participants With Uterine Extension of Hysterotomy

    Obstetrician determined whether the subject had an uterine extension.

    During cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

  • Umbilical Artery Blood pH

    Measure of umbilical artery blood pH

    At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

  • Number of Participants With Deliveries After Which Neonate is Admitted to NICU

    After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

  • Number of Participants With Deliveries in Which Cord Blood Base Deficit is More Negative Than or Equal to Negative 12

    A cord blood base deficit more negative than negative 12 is abnormal and a sign of metabolic acidosis.

    At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

  • APGAR at 5 Minutes

    The APGAR scale is determined by evaluating the newborn baby on five simple criteria -- Appearance, Pulse, Grimace, Activity, Respiration -- on a scale from zero to two, then summing up the five values thus obtained. The resulting APGAR score ranges from zero to 10. Zero is the worst possible score and 10 is the highest possible score.

    Immediately after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

Secondary Outcomes (3)

  • Fetal Extraction Time in Seconds

    At time of cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

  • Total Operative Time in Minutes

    After cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

  • Surgical Blood Loss

    During and after cesarean delivery, estimated to be within 4 hours after diagnosis of second stage arrest

Study Arms (2)

Intravenous Nitroglycerin

EXPERIMENTAL

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

Drug: intravenous nitroglycerin

Intravenous Saline

NO INTERVENTION

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

Interventions

intravenous nitroglycerinDRUG

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

Intravenous Nitroglycerin

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University California San Francisco-Labor and Delivery

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • 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.

    PMID: 27405400RESULT

Results Point of Contact

Title
Jennifer Lucero, MD
Organization
University of California, San Francisco
jennifer.lucero@ucsf.edu
415-476-5535

Study Officials

  • Jennifer M Lucero, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

October 16, 2014

Study Start

October 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

May 19, 2020

Results First Posted

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)