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Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

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ClinicalTrials.gov Identifier: NCT02338830
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

Study Description
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Brief Summary:
To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix

Condition or disease Intervention/treatment Phase
Premature Labour Drug: Progesterone Phase 4

Detailed Description:
Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
Study Start Date : June 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Progesterone group
Women received vaginal progesterone suppositories
 Drug: Progesterone
Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age
Other Name: Cyclogest
No Intervention: No treatment group
Women received no treatment


Outcome Measures
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Primary Outcome Measures :
  1. Preterm labor before 34 weeks [ Time Frame: Up to 34 weeks gestational age ]

Secondary Outcome Measures :
  1. Neonatal respiratory distress syndrome (RDS) [ Time Frame: At birth ]
  2. Early neonatal death (END). [ Time Frame: One month after birth ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women pregnant in dichorionic twins.
  • Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age.
  • No symptoms, signs or other risk factors for preterm labor.

Exclusion Criteria:

  • Age < 20 years or > 35 years.
  • Known allergy or contraindication (relative or absolute) to progesterone therapy.
  • Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI).
  • Monochorionic twins.
  • Known major fetal structural or chromosomal abnormality.
  • Intrauterine death of one fetus or death of both fetuses.
  • Fetal reduction in current pregnancy.
  • Cervical cerclage in current pregnancy.
  • Medical conditions that may lead to preterm delivery.
  • Rupture of membranes.
  • Vaginal bleeding.
Contacts and Locations
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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): NCT02338830


Locations
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Egypt
Obstetrics and Gynecology Department in Mansoura University Hospital
Mansoura, Dakahlia, Egypt, 35111
Private practice settings
Mansoura, Dakahlia, Egypt
Sponsors and Collaborators
Mohamed Sayed Abdelhafez
Investigators
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Principal Investigator: Waleed El-refaie, Dr Mansoura University
Study Director: Mohamed S Abdelhafez, Dr Mansoura University
Study Chair: Ahmed M Badawy, Prof Mansoura University
More Information
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Responsible Party: Mohamed Sayed Abdelhafez, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02338830    
Other Study ID Numbers: WR1
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015
Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
Twins
Preterm labor
Progesterone
Short cervix
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