N/A
N=36
Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor
Obstetric Labor, Premature
Bottom Line
View on ClinicalTrials.gov: NCT03129945 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants With Delay of Preterm Delivery by 48 Hours. — 15; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nifedipine (Drug); Indomethacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Irvine
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Delay of Preterm Delivery by 48 Hours. |
15; 21 | — |
Summary
The purpose of this research study is to determine the best medication to stop preterm labor. Recent studies have identify nifedipine and indomethacin as the two medications that are most likely to delay delivery for 48 hours, decrease maternal side effects and decrease some complications related to preterm delivery to the neonate. Both of these medications are commonly used to stop pre-term labor, therefore it has become our institution's standard to use these two medications in the setting of preterm labor. There have been limited studies comparing these two medications directly.
A total of 450 participants will be asked to participate across all study sites.
Eligibility Criteria
Inclusion Criteria
- Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 140 weeks by gestational age (see dating below) is acceptable.
- Gestational age at randomization between 240 weeks to 315 weeks by using the dating determinations as below
- Preterm labor with intact membranes. Preterm labor is defined as at least 6 regular uterine contractions in 60 minutes either seen on tocodynamometer, palpated by health providers and/or subjectively felt by the patient and at least one of the following:
- Associated with cervical change by cervical dilation greater than or equal to 1cm OR effacement greater than or equal to 25 to 50%
- Cervix greater than or equal to 2cm dilated on initial digital exam
- At least 75% effaced on initial digital exam
- Short cervical length (defined by each institution's policy) as obtained by transvaginal cervical sonography [in general, this is defined as a measurement of 2.0 - 2.5 cm or less] and/or a positive fetal fibronectin test (defined as a level greater than 50ng/mL).
- Intact membranes
- 18 years of age or older
Exclusion Criteria
- Fetal demise, or known major fetal anomaly, including cardiac anomaly and hydrops
- Maternal contraindication to nifedipine: preload cardiac lesions or maternal hypotension (systolic blood pressure less than 100 or diastolic blood pressure less than 60). A delayed dose can be given if blood pressure improves - it will be documented if dose is delayed, how long from scheduled dose it was delayed and reason for delay.
- Maternal contraindication to indomethacin: platelet dysfunction or bleeding disorders, hepatic dysfunction, gastrointestinal ulcerative disease, renal dysfunction and asthma
- Obstetrical contraindication to tocolysis not already mentioned: non reassuring fetal status, severe preeclampsia or eclampsia, maternal bleeding with hemodynamic instability, chorioamnionitis, preterm premature rupture of membranes
- Participation in another interventional study that influences neonatal morbidity or mortality
- Participation in this trial earlier in the pregnancy
- Maternal allergy to either indomethacin or nifedipine
- Maternal allergy to aspirin and other NSAIDs.
- Maternal hypertension requiring treatment.
- Maternal kidney disorder that would require adjustment in magnesium dosing.
Data sourced from ClinicalTrials.gov (NCT03129945). 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.