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Comparing Double Dose of Vaginal Progesterone to no Treatment for Prevention of Preterm Birth in Twins and Short Cervix

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ClinicalTrials.gov Identifier: NCT02329535
Recruitment Status : Terminated (Results from similar research were already published)
First Posted : December 31, 2014
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Noah Zafran, HaEmek Medical Center, Israel

Brief Summary:
Twin pregnancies are more likely to be delivered preterm than singleton pregnancies. Vaginal progesterone administration (200 mg Utrogestan) to asymptomatic women with a singleton pregnancy and sonographic short cervix reduced the risk of preterm birth (PTB) and neonatal morbidity and mortality, yet not proved efficient in twins' pregnancy. The investigators' hypothesis is that a higher dose of vaginal micronized progesterone will be more effective in preventing PTD. The objectives of the study is to compare the rate of preterm birth and perinatal morbidity and mortality in a twin pregnancy with short cervical length treated with vaginal 400 mg of micronized progesterone to no treatment. The study is Randomized, open label, of twin pregnancy between 16-26 weeks of gestation with cervical length under 25 mm. Women will be randomly assigned to either treatment or no treatment group. Progesterone treatment will be given until 36 weeks of gestation. Other management will be according to standard protocol.

Condition or disease Intervention/treatment Phase
Premature Birth Drug: Micronized progesterone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparing a Double Dose of Vaginal Progesterone to no Treatment for the Prevention of Preterm Birth in Twins Pregnancy and Short Cervix
Study Start Date : January 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
Treatment with 400 mg Micronized progesterone (Utrogestan) daily up to 6 weeks of geastation
Drug: Micronized progesterone
vaginal caps 400 mg daily up to 36 weeks of gestation
Other Name: Utrogestan

No Intervention: No treatment
No treatment. Regular follow up



Primary Outcome Measures :
  1. Preterm delivery [ Time Frame: up to 25 weeks from randomization ]
    Rate of preterm delivery before 37.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Twin gestation
  • Certain dating (documented first trimester ultrasound, or a reliable menstrual date confirmed by an ultrasound performed before 20 weeks of gestation)
  • Age > 18 years
  • Gestational age 16-26
  • Cervical length<25 mm
  • Intact membranes
  • Informed consent

Exclusion Criteria:

  • Major malformation or chromosomal abnormality to at least one fetus
  • Higher order pregnancy
  • Mocochorional-monoamniotic twin
  • Death of one fetus
  • Cervical dilatation >3 cm
  • Chronic medical conditions that would interfere with study participation or evaluation of the treatment (e.g. seizures, psychiatric disorders, uncontrolled chronic hypertension, congestive heart failure, chronic renal failure, uncontrolled diabetes mellitus with end-organ dysfunction, active thrombophlebitis or a thromboembolic disorder, history of hormone-associated thrombophlebitis or thromboembolic disorders, active liver dysfunction or disease, known or suspected malignancy of the breast or genital organs)

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): NCT02329535


Locations
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Israel
Haemek Medical Center
Afula, Israel
The Nazareth hospital
Nazareth, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Study Chair: Raed Salim, MD Head of delivery room, Department of OB-GYN, Emek medical center, Afula, Israel

Publications:

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Responsible Party: Noah Zafran, Senion physician OB-GYN, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02329535     History of Changes
Other Study ID Numbers: EMC-005413-CTIL
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs