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Completed

NCT Number: NCT02265965

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

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.

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Key information

Conditions

Prolonged Second Stage of Labor

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University California San Francisco-Labor and Delivery

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

women 37weeks or greater gestation diagnosed with second stage arrest of descent undergoing cesarean delivery -

Exclusion criteria

elective, active phase arrest cesarean delivery, successful operative vaginal delivery

-

Treatment and study plan

Intravenous Nitroglycerin

Drug

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

Primary outcomes

  1. Number of Participants With Uterine Extension of Hysterotomy

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

    Obstetrician determined whether the subject had an uterine extension.

  2. Umbilical Artery Blood pH

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

    Measure of umbilical artery blood pH

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

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

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

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

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

  5. APGAR at 5 Minutes

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

    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.

Secondary outcomes

  1. Fetal Extraction Time in Seconds

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

    Time from uterine incision to delivery (body of neonate fully extracted from uterus)

  2. Total Operative Time in Minutes

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

    Time from uterine incision to out of room

  3. Surgical Blood Loss

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

    Total blood loss will be measured

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Randomized Controlled Trial of IV Nitroglycerin in Cesarean Deliveries After Second Stage Arrest for the Prevention of Uterine Extension

Acronym: NITRO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2014
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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