Indomethacin for Tocolysis of Preterm Labor
Purpose
Indomethacin for tocolysis for 48 hours vs placebo
Condition
- Preterm Labor
Eligibility
- Eligible Ages
- Between 16 Years and 50 Years
- Eligible Genders
- Female
- Accepts 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)
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
The patient will be given a loading dose of 50mg placebo by mouth followed by 25mg by mouth every six hours for a total of eight doses over 48 hours. |
|
|
Active Comparator Indomethacin |
The patient will be given a loading dose of 50mg indomethacin by mouth followed by 25mg by mouth every six hours for a total of eight doses over 48 hours. |
|
More Details
- Status
- Withdrawn
- Sponsor
- MetroHealth Medical Center
Study Contact
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.