Back to resultsVaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor
Primary Purpose
Preterm Labor
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
micronized progesterone 400 mg (Utrogestan)
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Labor
Eligibility Criteria
Inclusion Criteria:
- 18 years of age
- Tocolytic treatment between 24+0 and 34+0 weeks
- Patient's consent to participate in this study
- 24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment
- Arrest of preterm labor
Exclusion Criteria
Contraindication to ongoing pregnancy including:
- 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
- Evidence of significant placental abruption (contractions and significant bleeding from placental origin)
- Intrauterine fetal death diagnosed at the time of admission
- Major fetal malformation
- Known maternal allergy to progesterone
- Current use of progesterone at the time of admission
- Epilepsy
- Breast cancer
- PPROM (preterm premature rupture of membranes) during testing for eligibility
- Age below 18 years
- 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)
- History of deep vein thrombosis
- Major active psychiatric disorders (major affective disorders and psychotic disorders)
- Uncontrolled chronic hypertension
- Heart failure
- Chronic renal failure
- Pre-gestational diabetes with known target organ damage
- History of spontaneous preterm delivery
- Previous tocolytic treatment during the current pregnancy
Sites / Locations
- Poriya Medical Center
- Emek Medical center
- Assuta Ashdod medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
micronized progesterone 400 mg
No treatment
Arm Description
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
No treatment
Outcomes
Primary Outcome Measures
The mean number of days from enrollment to delivery
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
Secondary Outcome Measures
Number of days from recruitment to repeated preterm labor episode or preterm premature rupture of membranes, up to 37 weeks of gestation
Pregnancy prolongation beyond one week
Need for repeated acute tocolysis
Number of hospitalizations and length of stay until 36.6 gestational weeks
The rate of preterm spontaneous labor (defined as spontaneous labor or preterm premature rupture of membranes prior to 37 weeks of gestation)
Admission to the NICU (neonatal intensive care unit)
Length of NICU stay
Length of neonate 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 (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
Adverse medication reactions
Postpartum hemorrhage
Revision of uterine and cervix and reasons for the procedure
Urinary tract or vulvovaginal infection until 36.6 weeks
Full Information
NCT ID
NCT02430233
First Posted
April 20, 2015
Last Updated
February 27, 2023
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT02430233
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
February 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
micronized progesterone 400 mg
Arm Type
Experimental
Arm Description
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Drug
Intervention Name(s)
micronized progesterone 400 mg (Utrogestan)
Other Intervention Name(s)
Utrogestan- 200mg×2 PV(per vagina) per day
Intervention Description
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
Primary Outcome Measure Information:
Title
The mean number of days from enrollment to delivery
Time Frame
Up to 18 weeks
Title
The rate of preterm spontaneous delivery
Description
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
Secondary Outcome Measure Information:
Title
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
Title
Pregnancy prolongation beyond one week
Time Frame
Up to 18 weeks
Title
Need for repeated acute tocolysis
Time Frame
Up to 13 weeks
Title
Number of hospitalizations and length of stay until 36.6 gestational weeks
Time Frame
Up to 13 weeks
Title
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
Title
Admission to the NICU (neonatal intensive care unit)
Time Frame
From delivery and up to 28 days
Title
Length of NICU stay
Time Frame
From delivery and up to 3 months
Title
Length of neonate hospital stay
Time Frame
From delivery and up to 3 months
Title
Fetal/neonatal death
Time Frame
Around delivery
Title
Birth weight and the rate of small for gestational age neonates
Time Frame
Around delivery
Title
The rate of neonatal complications
Description
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
Title
The rate of chorioamnionitis and endometritis
Time Frame
around delivery and up to 1 week post-partum
Title
Adverse medication reactions
Time Frame
Up to 13 weeks
Title
Postpartum hemorrhage
Time Frame
From delivery and up to 1 week post-partum
Title
Revision of uterine and cervix and reasons for the procedure
Time Frame
During the 48 hours from delivery
Title
Urinary tract or vulvovaginal infection until 36.6 weeks
Time Frame
Up to 13 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age
Tocolytic treatment between 24+0 and 34+0 weeks
Patient's consent to participate in this study
24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment
Arrest of preterm labor
Exclusion Criteria
Contraindication to ongoing pregnancy including:
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
Evidence of significant placental abruption (contractions and significant bleeding from placental origin)
Intrauterine fetal death diagnosed at the time of admission
Major fetal malformation
Known maternal allergy to progesterone
Current use of progesterone at the time of admission
Epilepsy
Breast cancer
PPROM (preterm premature rupture of membranes) during testing for eligibility
Age below 18 years
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)
History of deep vein thrombosis
Major active psychiatric disorders (major affective disorders and psychotic disorders)
Uncontrolled chronic hypertension
Heart failure
Chronic renal failure
Pre-gestational diabetes with known target organ damage
History of spontaneous preterm delivery
Previous tocolytic treatment during the current pregnancy
Facility Information:
Facility Name
Poriya Medical Center
City
Tiberias
State/Province
North
ZIP/Postal Code
15208
Country
Israel
Facility Name
Emek Medical center
City
Afula
State/Province
Please Select
ZIP/Postal Code
18100
Country
Israel
Facility Name
Assuta Ashdod medical center
City
Ashdod
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor
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