Clinical trial NCT02430233: Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor
Official title: Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor - Randomized Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Labor
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The mean number of days from enrollment to delivery
timeFrame: Up to 18 weeks
measure: The rate of preterm spontaneous delivery
timeFrame: Up to 13 weeks
Secondary outcomes:
measure: Number of days from recruitment to repeated preterm labor episode or preterm premature rupture of membranes, up to 37 weeks of gestation
timeFrame: Up to 13 weeks
measure: Pregnancy prolongation beyond one week
timeFrame: Up to 18 weeks
measure: Need for repeated acute tocolysis
timeFrame: Up to 13 weeks
measure: Number of hospitalizations and length of stay until 36.6 gestational weeks
timeFrame: Up to 13 weeks
measure: The rate of preterm spontaneous labor (defined as spontaneous labor or preterm premature rupture of membranes prior to 37 weeks of gestation)
timeFrame: Up to 13 weeks
measure: Admission to the NICU (neonatal intensive care unit)
timeFrame: From delivery and up to 28 days
measure: Length of NICU stay
timeFrame: From delivery and up to 3 months
measure: Length of neonate hospital stay
timeFrame: From delivery and up to 3 months
measure: Fetal/neonatal death
timeFrame: Around delivery
measure: Birth weight and the rate of small for gestational age neonates
timeFrame: Around delivery
measure: The rate of neonatal complications
timeFrame: From delivery and up to 3 months
measure: The rate of chorioamnionitis and endometritis
timeFrame: around delivery and up to 1 week post-partum
measure: Adverse medication reactions
timeFrame: Up to 13 weeks
measure: Postpartum hemorrhage
timeFrame: From delivery and up to 1 week post-partum
measure: Revision of uterine and cervix and reasons for the procedure
timeFrame: During the 48 hours from delivery
measure: Urinary tract or vulvovaginal infection until 36.6 weeks
timeFrame: Up to 13 weeks
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: Poriya Medical Center
state: North
city: Afula
country: Israel
facility: Emek Medical center
state: Please Select
city: Ashdod
country: Israel
facility: Assuta Ashdod medical center
Study officials:
References: