Indomethacin for Tocolysis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 16 - 50 |
| Updated: | 7/19/2018 |
| Start Date: | June 1, 2019 |
| End Date: | December 2021 |
| Contact: | Kelly S Gibson, MD |
| Email: | kgibson@metrohealth.org |
| Phone: | 2167787076 |
Randomized, Placebo Controlled Trial of Indomethacin for Tocolysis
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.
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.
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)
We found this trial at
1
site
2500 Metrohealth Dr
Cleveland, Ohio 44109
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Kelly S Gibson, MD
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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