A Phase 4 interventional study of micronized progesterone 400 mg (Utrogestan) in Preterm Labor, sponsored by HaEmek Medical Center, Israel. Completed at 3 sites in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by HaEmek Medical Center, Israel · Phase 4, Interventional, and Treatment
Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.
Since progesterone derivatives are useful in preventing preterm labor in cases of risk factors or previous preterm labor, we hypothesize that they will also show efficacy in pregnancy prolongation in women whose preterm labor was arrested following tocolytic treatment.
Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.
This study has the potential to find a treatment to prevent preterm labor and thus to reduce neonatal morbidity and mortality.
255 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.
This study's enrollment of 129 is above the median of 110 across 155 interventional studies indexed under Obstetric Labor, Premature.
Browse Obstetric Labor, Premature studies →HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Contraindication to ongoing pregnancy including:
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
Drug: micronized progesterone 400 mg (Utrogestan)
No treatment
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
Also known as: Utrogestan- 200mg×2 PV(per vagina) per day
The mean number of days from enrollment to delivery
Time frame: Up to 18 weeks
The rate of preterm spontaneous delivery
defined as spontaneous labor or preterm delivery following induction/cesarean section due to preterm premature rupture of membranes prior to 37 weeks of gestation
Time frame: Up to 13 weeks
Number of days from recruitment to repeated preterm labor episode or preterm premature rupture of membranes, up to 37 weeks of gestation
Time frame: Up to 13 weeks
Pregnancy prolongation beyond one week
Time frame: Up to 18 weeks
Need for repeated acute tocolysis
Time frame: Up to 13 weeks
Number of hospitalizations and length of stay until 36.6 gestational weeks
Time frame: Up to 13 weeks
The rate of preterm spontaneous labor (defined as spontaneous labor or preterm premature rupture of membranes prior to 37 weeks of gestation)
Time frame: Up to 13 weeks
Admission to the NICU (neonatal intensive care unit)
Time frame: From delivery and up to 28 days
Length of NICU stay
Time frame: From delivery and up to 3 months
Length of neonate hospital stay
Time frame: From delivery and up to 3 months
Fetal/neonatal death
Time frame: Around delivery
Birth weight and the rate of small for gestational age neonates
Time frame: Around delivery
The rate of neonatal complications
including transient tachypnea, RDS (respiratory distress syndrome), bronchopulmonary dysplasia, ventilatory support, supplemental oxygen, IVH (intraventricular hemorrhage), NEC (necrotizing enterocolitis), PDA (patent ductus arteriosus), retinopathy, neonatal sepsis, and congenital abnormalities not previously identified (specifically genital abnormalities).
Time frame: From delivery and up to 3 months
The rate of chorioamnionitis and endometritis
Time frame: around delivery and up to 1 week post-partum
Adverse medication reactions
Time frame: Up to 13 weeks
Postpartum hemorrhage
Time frame: From delivery and up to 1 week post-partum
Revision of uterine and cervix and reasons for the procedure
Time frame: During the 48 hours from delivery
Urinary tract or vulvovaginal infection until 36.6 weeks
Time frame: Up to 13 weeks
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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HaEmek Medical Center, Israel