Preterm Labor
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGmicronized progesterone 400 mg (Utrogestan)
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age 2. Tocolytic treatment between 24+0 and 34+0 weeks 3. Patient's consent to participate in this study 4. 24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment 5. Arrest of preterm labor
Exclusion criteria
1. Contraindication to ongoing pregnancy including: 1. Suspected amnionitis during testing for eligibility- evidence of active infection including temperature ≥ 38.0°C and uterine tenderness, foul-smelling vaginal discharge, maternal tachycardia of 120 beats per minute or greater, or sustained fetal tachycardia of 160 beats per minute or greater 2. Evidence of significant placental abruption (contractions and significant bleeding from placental origin) 3. Intrauterine fetal death diagnosed at the time of admission 2. Major fetal malformation 3. Known maternal allergy to progesterone 4. Current use of progesterone at the time of admission 5. Epilepsy 6. Breast cancer 7. PPROM (preterm premature rupture of membranes) during testing for eligibility 8. Age below 18 years 9. Known active liver disease (elevated liver enzymes at twice the upper normal limit according to medical history or blood test that were taking doring standard medical care) 10. History of deep vein thrombosis 11. Major active psychiatric disorders (major affective disorders and psychotic disorders) 12. Uncontrolled chronic hypertension 13. Heart failure 14. Chronic renal failure 15. Pre-gestational diabetes with known target organ damage 16. History of spontaneous preterm delivery 17. Previous tocolytic treatment during the current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean number of days from enrollment to delivery | Up to 18 weeks | — |
| The rate of preterm spontaneous delivery | Up to 13 weeks | defined as spontaneous labor or preterm delivery following induction/cesarean section due to preterm premature rupture of membranes prior to 37 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for repeated acute tocolysis | Up to 13 weeks | — |
| Number of hospitalizations and length of stay until 36.6 gestational weeks | 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) | Up to 13 weeks | — |
| Admission to the NICU (neonatal intensive care unit) | From delivery and up to 28 days | — |
| Length of NICU stay | From delivery and up to 3 months | — |
| Length of neonate hospital stay | From delivery and up to 3 months | — |
| Fetal/neonatal death | Around delivery | — |
| Number of days from recruitment to repeated preterm labor episode or preterm premature rupture of membranes, up to 37 weeks of gestation | Up to 13 weeks | — |
| The rate of neonatal complications | From delivery and up to 3 months | 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). |
| The rate of chorioamnionitis and endometritis | around delivery and up to 1 week post-partum | — |
| Adverse medication reactions | Up to 13 weeks | — |
| Postpartum hemorrhage | From delivery and up to 1 week post-partum | — |
| Revision of uterine and cervix and reasons for the procedure | During the 48 hours from delivery | — |
| Urinary tract or vulvovaginal infection until 36.6 weeks | Up to 13 weeks | — |
| Birth weight and the rate of small for gestational age neonates | Around delivery | — |
| Pregnancy prolongation beyond one week | Up to 18 weeks | — |
Countries
Israel
Outcome results
None listed