Preterm Labor
Conditions
Keywords
preterm labor, tocolysis, indomethacin
Brief summary
Indomethacin for tocolysis for 48 hours vs placebo
Detailed description
Background: Indomethacin is frequently used as a tocolytic, however there is currently only scant evidence to support its efficacy. Goals: To delay preterm delivery by 48 hours and to examine longer latency periods and maternal and neonatal outcomes Methods: Randomized placebo-controlled trial of indomethacin for tocolysis. Women with a singleton pregnancy between 23w0d and 31w6d in preterm labor randomly assigned to 50mg indomethacin by mouth followed by 25mg by mouth every 6hour for 48 hours or placebo. Patients receive betamethasone for fetal lung maturity, if not previously administered, and magnesium sulfate for neuroprotection. Ultrasound performed before initiation of study drug and after completion of study medication for amniotic fluid index and fetal cardiac assessment.
Interventions
DRUGIndomethacin
Study drug
DRUGPlacebo
Control drug
Sponsors
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Preterm labor as defined by regular uterine contractions (at least 6/hour) with cervical change of at least 1 cm or cervical shortening on transvaginal ultrasound less than 25mm of functional length * Gestational age 23w0d to 31w6d weeks * Singleton * ≥ 18 years old * Able to consent in English
Exclusion criteria
* Major congenital anomalies associated with an increased risk of newborn death * Multiple fetal gestation (2+) * Known intrauterine fetal demise * Non-reassuring fetal status requiring delivery * Preterm premature rupture of membranes (PPROM) * Suspected or known intrauterine infection * Placenta previa * Maternal allergy or contraindication to indomethacin (peptic ulcer disease, thrombocytopenia, coagulopathy, renal or hepatic dysfunction) * Inevitable delivery (cervix ≥6cm dilated)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| delivery within 48 hours | 48 hours after enrollment | The percentage of patients remaining undelivered after 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| delivery within 7 days | 7 days after enrollment | The percentage of patients remaining undelivered after 7 days |
| delivery before 37 weeks | participants will be followed for the duration of pregnancy through their postpartum period, an expected time of up to 20 weeks | The percentage of patients remaining undelivered until 37 weeks gestational age |
| Maternal and Fetal Complications | participants will be followed for the duration of pregnancy through their postpartum period and neonatal hospital stay, an expected time of up to 24 weeks | composite of maternal intolerance of the drug, birth weight, gestational age, neonatal morbidities, changes in amniotic fluid volume, fetal cardiac assessment, or premature constriction of the ductus arteriosus. |
Countries
United States
Outcome results
None listed