Status:
WITHDRAWN
Indomethacin for Tocolysis of Preterm Labor
Lead Sponsor:
MetroHealth Medical Center
Conditions:
Preterm Labor
Eligibility:
FEMALE
16-50 years
Phase:
EARLY_PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01869361
Start Date
August 1 2020
End Date
November 23 2021
Last Update
December 7 2021
Active Locations (1)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109