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

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ClinicalTrials.gov Identifier: NCT02430233
Recruitment Status : Recruiting
First Posted : April 30, 2015
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Zohar Nachum, HaEmek Medical Center, Israel

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.

Condition or disease Intervention/treatment Phase
Preterm Labor Drug: micronized progesterone 400 mg (Utrogestan) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor - Randomized Double Blind Placebo Controlled Trial
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: micronized progesterone 400 mg
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
Drug: micronized progesterone 400 mg (Utrogestan)
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
Other Name: Utrogestan- 200mg×2 PV(per vagina) per day

No Intervention: No treatment
No treatment



Primary Outcome Measures :
  1. The mean number of days from enrollment to delivery [ Time Frame: Up to 18 weeks ]
  2. The rate of preterm spontaneous delivery [ Time Frame: 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 Outcome Measures :
  1. 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 ]
  2. Pregnancy prolongation beyond one week [ Time Frame: Up to 18 weeks ]
  3. Need for repeated acute tocolysis [ Time Frame: Up to 13 weeks ]
  4. Number of hospitalizations and length of stay until 36.6 gestational weeks [ Time Frame: Up to 13 weeks ]
  5. 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 ]
  6. Admission to the NICU (neonatal intensive care unit) [ Time Frame: From delivery and up to 28 days ]
  7. Length of NICU stay [ Time Frame: From delivery and up to 3 months ]
  8. Length of neonate hospital stay [ Time Frame: From delivery and up to 3 months ]
  9. Fetal/neonatal death [ Time Frame: Around delivery ]
  10. Birth weight and the rate of small for gestational age neonates [ Time Frame: Around delivery ]
  11. The rate of neonatal complications [ Time Frame: 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).

  12. The rate of chorioamnionitis and endometritis [ Time Frame: around delivery and up to 1 week post-partum ]
  13. Adverse medication reactions [ Time Frame: Up to 13 weeks ]
  14. Postpartum hemorrhage [ Time Frame: From delivery and up to 1 week post-partum ]
  15. Revision of uterine and cervix and reasons for the procedure [ Time Frame: During the 48 hours from delivery ]
  16. Urinary tract or vulvovaginal infection until 36.6 weeks [ Time Frame: Up to 13 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430233


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

Locations
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Israel
Emek Medical center Recruiting
Afula, Please Select, Israel, 18100
Contact: Zohar Nachum, MD    972-46495483    nachum_zo@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel

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Responsible Party: Zohar Nachum, Principal Investigator, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02430233     History of Changes
Other Study ID Numbers: 0080-13
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs