N/A
N=143
Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery
Postpartum Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02411916 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Change in Hemoglobin — 1.08; 1.20 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- misoprostol (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- New York City Health and Hospitals Corporation
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin |
1.08; 1.20 | — |
Summary
This document defines the Clinical Investigation Protocol for a study designed to determine whether blood loss after spontaneous vaginal delivery is altered by the addition of misoprostol administration to the standard use of intravenous oxytocin after delivery. The protocol is an open-label randomized prospective trial to be carried out at Queens Hospital Center.
Blood loss will be measured indirectly by comparing the maternal hemoglobin and hematocrit levels on admission in labor to those obtained within 24 hours after delivery.
Eligibility Criteria
Inclusion criteria (A patient will be considered for inclusion in the study if she meets all of the following criteria):
- She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit
- She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit
- She has had fewer than four prior vaginal deliveries.
- She reports no allergy to misoprostol.
The following factors or conditions will exclude a patient from consideration as a subject:
- The fetus has a known major fetal malformation or chromosome abnormality
- The gestation is multiple.
- There is a breech or other malpresentation
- The patient reports involvement in another clinical trial currently or previously in this pregnancy.
- The patient is expected to have a cesarean delivery.
- The patient had a prior cesarean delivery.
- There has been an intrauterine fetal death.
- There is polyhydramnios (amniotic fluid index >22 cm).
- Presence of acute or chronic renal disease
- Presence of preeclampsia
Exclusion criteria (Of subjects who enter the study, the development of certain conditions will exclude them post hoc from receiving misoprostol under the protocol, and from the data analysis. These conditions include):
- Unanticipated cesarean delivery.
- Performance of episiotomy (third and fourth degree extensions will be excluded).
- Vaginal or cervical laceration, or perineal laceration of more than second degree in depth.
- Severe postpartum hemorrhage requiring intervention immediately after delivery.
- Uterine rupture
- Placental abruption.
- Patient withdrawal of consent.
Data sourced from ClinicalTrials.gov (NCT02411916). 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.