Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor
NCT ID: NCT02430233
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
129 participants
INTERVENTIONAL
2018-12-19
2023-02-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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micronized progesterone 400 mg
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
micronized progesterone 400 mg (Utrogestan)
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
No treatment
No treatment
No interventions assigned to this group
Interventions
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micronized progesterone 400 mg (Utrogestan)
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. 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
18 Years
FEMALE
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Zohar Nachum
Principal Investigator
Locations
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Poriya Medical Center
Tiberias, North, Israel
Emek Medical center
Afula, Please Select, Israel
Assuta Ashdod medical center
Ashdod, , Israel
Countries
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References
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Nachum Z, Ganor Paz Y, Massalha M, Wated M, Harel N, Yefet E. Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419894. doi: 10.1001/jamanetworkopen.2024.19894.
Other Identifiers
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0080-13
Identifier Type: -
Identifier Source: org_study_id
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