Vaginal Indomethacin for Preterm Labor

Study Overview
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Brief Summary
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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.

Official Title
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Vaginal Indomethacin Versus Oral Nifedipine for Preterm Labor; a Randomized Controlled Trial

Conditions
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Obstetric Labor, Premature

Intervention / Treatment
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* Drug: Indomethacin
* Drug: Nifedipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indomethacin group<br>Group of patients receiving Indomethacin for preterm labor treatment. | Drug: Indomethacin<br>* Per vagina administration of 100 mg followed by a second 100 mg dosage the following day<br>* Other names: Indomed;|
| Active Comparator: Nifedipine group<br>Group of patients receiving Nifedipine for preterm labor treatment. | Drug: Nifedipine<br>* Per os administration according to current protocol of 20mg each 20 minutes for 1 hour followed by 20 mg q8 for 48 hours.<br>* Other names: Pressolat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to delivery | The time from administration of intervention do delivery | through study completion, approximately 1 year | 
| Gestational age | Days from last menstrual period | through study completion, approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of preterm deliveries | Rate of deliveries under 37+0/7 weeks of gestation | through study completion, approximately 1 year | 
| Rate of remote from term deliveries | Rate of deliveries under 34+0/7 weeks of gestation | through study completion, approximately 1 year | 
| Rate of extreme preterm deliveries | Rate of deliveries under 28+0/7 weeks of gestation | through study completion, approximately 1 year | 
| neonatal immediate outcomes | Neonatal Apgar scores | through study completion, approximately 1 year | 
| Neonatal immediate outcome | Neonatal umbilical cord pH levels | through study completion, approximately 1 year | 
| Neonatal birth weight | birth wight as recorded in chart in grams | through study completion, approximately 1 year | 
| Neonatal outcomes | neonatal intensive care unit administration rate | through study completion, approximately 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm labor, tocolysis, prematurity