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Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor

Information source: HaEmek Medical Center, Israel
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Preterm Labor

Intervention: micronized progesterone 400 mg (Utrogestan) (Drug); Placebo (Other)

Phase: N/A

Status: Not yet recruiting

Sponsored by: HaEmek Medical Center, Israel

Overall contact:
enav yefet, MD/PhD, Phone: +972-4-6494516, Email: enavy1@gmail.com

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 placebo.

Clinical Details

Official title: Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor - Randomized Double Blind Placebo Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The rate of preterm spontaneous labor (defined as spontaneous labor or preterm labor following induction due to preterm premature rupture of membranes prior to 37 weeks of gestation).

Secondary outcome:

Number of days from treatment initiation to labor

Pregnancy prolongation beyond one week

Need for repeated acute tocolysis

Admission to the NICU (neonatal intensive care unit)

Length of NICU stay

Length of hospital stay

Fetal/neonatal death

Birth weight and the rate of small for gestational age neonates

The rate of neonatal complications including transient tachypnea, RDS, bronchopulmonary dysplasia, ventilatory support, supplemental oxygen, IVH, NEC, PDA, retinopathy, neonatal sepsis, and congenital abnormalities not previously identified

The rate of chorioamnionitis

Adverse medication reactions

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 placebo. This study has the potential to find a treatment to prevent preterm labor and thus to reduce neonatal morbidity and mortality.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Gestational age between 24+0 and 34+0 weeks

Exclusion Criteria: 1. Contraindication to ongoing pregnancy including:

- Suspected amnionitis - 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

- Evidence of significant placental abruption

- Intrauterine fetal death diagnosed at the time of admission

2. Major fetal malformation 3. Known maternal allergy to progesterone or placebo drug components 4. Current use of progesterone at the time of admission 5. Epilepsy 6. Breast cancer 7. PPROM (preterm premature rupture of membranes) 8. Age below 18 years 9. Active liver disease 10. History of thrombophlebitis 11. Major psychiatric disorders 12. Uncontrolled chronic hypertension 13. Heart failure 14. Chronic renal failure 15. Pre-gestational diabetes with known target organ damage

Locations and Contacts

enav yefet, MD/PhD, Phone: +972-4-6494516, Email: enavy1@gmail.com

Additional Information

Starting date: August 2015
Last updated: April 29, 2015

Page last updated: August 23, 2015

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