Vaginal Indomethacin for Preterm Labor
- Conditions
- Obstetric Labor, Premature
- Interventions
- Registration Number
- NCT04404686
- Lead Sponsor
- Hadassah Medical Organization
- Brief Summary
Indometacin is a cyclooxygenase agent from the NSAID family that has been used to treat preterm contractions since the 70's by preventing the synthesis of prostaglandins. It has been shown to be significantly more effective than placebo and postpone labor for 7-10 days, prolong pregnancies above 37 weeks of gestation and reduce numbers of small for gestational age neonates.
Nifedipine is a calcium channel blocker agent that has been shown to reduce rates of labor within 48 hours from treatment.
Previous studies comparing rectal Indometacin to oral nifedipine were inconclusive.
Prostaglandins are synthesized in the uterus and the uterine cervix and therefore local administration of Indometacin may be more effective than other forms of administration, as been shown in a previous study.
In this study we aim to compare vaginal Indometacin administration to a commonly used tocolytic agent, nifedipine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- Singe fetus
- Gestational age between 24+0/7 and 31+6/7
- At least one uterine contraction in ten minutes for at least 20 minutes upon tocography admission
- Cervical parameters: 1 cm dilation or more or 80% cervical effacement or cervical length 20mm or less
- Rupture of membranes
- Vaginal bleeding
- Cervical dilation ≥5cm
- Known fetal malformations
- Fetal heart rate abnormalities
- Suspected placental abruption of adherent placental syndrome
- Known sensitivity to one of the drugs used in the study (Indometacin and nifedipine)
- Maternal hypotension and known aortic or mitral stenosis
- Presence of cervical cerclage
- Previous administration of tocolytic drugs in current pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Indomethacin group Indomethacin Group of patients receiving Indomethacin for preterm labor treatment. Nifedipine group Nifedipine Group of patients receiving Nifedipine for preterm labor treatment.
- Primary Outcome Measures
Name Time Method Gestational age through study completion, approximately 1 year Days from last menstrual period
Time to delivery through study completion, approximately 1 year The time from administration of intervention do delivery
- Secondary Outcome Measures
Name Time Method Neonatal birth weight through study completion, approximately 1 year birth wight as recorded in chart in grams
Rate of extreme preterm deliveries through study completion, approximately 1 year Rate of deliveries under 28+0/7 weeks of gestation
Neonatal outcomes through study completion, approximately 1 year neonatal intensive care unit administration rate
Rate of preterm deliveries through study completion, approximately 1 year Rate of deliveries under 37+0/7 weeks of gestation
neonatal immediate outcomes through study completion, approximately 1 year Neonatal Apgar scores
Rate of remote from term deliveries through study completion, approximately 1 year Rate of deliveries under 34+0/7 weeks of gestation
Neonatal immediate outcome through study completion, approximately 1 year Neonatal umbilical cord pH levels