Obstetric Labor, Premature
Conditions
Keywords
preterm labor, tocolysis, prematurity
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.
Interventions
DRUGIndomethacin
Per vagina administration of 100 mg followed by a second 100 mg dosage the following day
DRUGNifedipine
Per os administration according to current protocol of 20mg each 20 minutes for 1 hour followed by 20 mg q8 for 48 hours.
Sponsors
Sheba Medical Center
Soroka University Medical Center
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Caregivers will receive a closed envelope with the drug to be used. since the routes of administration are different, from that point on the caregiver and patient will be aware of chosen drug
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to delivery | through study completion, approximately 1 year | The time from administration of intervention do delivery |
| Gestational age | through study completion, approximately 1 year | Days from last menstrual period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of extreme preterm deliveries | through study completion, approximately 1 year | Rate of deliveries under 28+0/7 weeks of gestation |
| neonatal immediate outcomes | through study completion, approximately 1 year | Neonatal Apgar scores |
| Rate of preterm deliveries | through study completion, approximately 1 year | Rate of deliveries under 37+0/7 weeks of gestation |
| Neonatal birth weight | through study completion, approximately 1 year | birth wight as recorded in chart in grams |
| Neonatal outcomes | through study completion, approximately 1 year | neonatal intensive care unit administration rate |
| Neonatal immediate outcome | through study completion, approximately 1 year | Neonatal umbilical cord pH levels |
| Rate of remote from term deliveries | through study completion, approximately 1 year | Rate of deliveries under 34+0/7 weeks of gestation |
Contacts
Primary ContactHila Hochler, MD
Backup ContactHadas Lemberg, PhD
Outcome results
None listed