Phase 4
N=18
Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension
Prolonged Second Stage of Labor
Bottom Line
View on ClinicalTrials.gov: NCT02265965 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Uterine Extension of Hysterotomy — 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- intravenous nitroglycerin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Uterine Extension of Hysterotomy |
3; 4 | — |
| PRIMARY Umbilical Artery Blood pH |
7.3; 7.3 | — |
| PRIMARY Number of Participants With Deliveries After Which Neonate is Admitted to NICU |
1; 2 | — |
| PRIMARY Number of Participants With Deliveries in Which Cord Blood Base Deficit is More Negative Than or Equal to Negative 12 |
7; 11 | — |
| PRIMARY APGAR at 5 Minutes |
9; 9 | — |
| SECONDARY Fetal Extraction Time in Seconds |
104.9; 131 | — |
| SECONDARY Total Operative Time in Minutes |
68.3; 74.2 | — |
| SECONDARY Surgical Blood Loss |
935.7; 1036.4 | — |
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.
Eligibility Criteria
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
-
Data sourced from ClinicalTrials.gov (NCT02265965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.