Clinical trial NCT04404686: Vaginal Indomethacin for Preterm Labor
Official title: Vaginal Indomethacin Versus Oral Nifedipine for Preterm Labor; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Obstetric Labor, Premature
Keywords: preterm labor
tocolysis
prematurity
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
name: Soroka University Medical Center
First posted: 2020-05-27
Enrollment: 300
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to delivery
timeFrame: through study completion, approximately 1 year
measure: Gestational age
timeFrame: through study completion, approximately 1 year
Secondary outcomes:
measure: Rate of preterm deliveries
timeFrame: through study completion, approximately 1 year
measure: Rate of remote from term deliveries
timeFrame: through study completion, approximately 1 year
measure: Rate of extreme preterm deliveries
timeFrame: through study completion, approximately 1 year
measure: neonatal immediate outcomes
timeFrame: through study completion, approximately 1 year
measure: Neonatal immediate outcome
timeFrame: through study completion, approximately 1 year
measure: Neonatal birth weight
timeFrame: through study completion, approximately 1 year
measure: Neonatal outcomes
timeFrame: through study completion, approximately 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Hila Hochler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Reinebrant HE, Pileggi-Castro C, Romero CL, Dos Santos RA, Kumar S, Souza JP, Flenady V. Cyclo-oxygenase (COX) inhibitors for treating preterm labour. Cochrane Database Syst Rev. 2015 Jun 5;2015(6):CD001992. doi: 10.1002/14651858.CD001992.pub3.
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