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

Primary Purpose

Premature Birth

Status

Terminated

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Micronized progesterone

About this trial

This is an interventional prevention trial for Premature Birth

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Haemek Medical Center
The Nazareth hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

No treatment

Arm Description

Treatment with 400 mg Micronized progesterone (Utrogestan) daily up to 6 weeks of geastation

No treatment. Regular follow up

Outcomes

Primary Outcome Measures

Preterm delivery

Rate of preterm delivery before 37.

Secondary Outcome Measures

Full Information

NCT ID

NCT02329535

First Posted

November 30, 2014

Last Updated

August 16, 2017

Sponsor

HaEmek Medical Center, Israel

1. Study Identification

Unique Protocol Identification Number

NCT02329535

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Why Stopped

Results from similar research were already published

Study Start Date

January 2015 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Birth

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

Treatment with 400 mg Micronized progesterone (Utrogestan) daily up to 6 weeks of geastation

Arm Title

No treatment

Arm Type

No Intervention

Arm Description

No treatment. Regular follow up

Intervention Type

Drug

Intervention Name(s)

Micronized progesterone

Other Intervention Name(s)

Utrogestan

Intervention Description

vaginal caps 400 mg daily up to 36 weeks of gestation

Primary Outcome Measure Information:

Title

Preterm delivery

Description

Rate of preterm delivery before 37.

Time Frame

up to 25 weeks from randomization

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raed Salim, MD

Organizational Affiliation

Head of delivery room, Department of OB-GYN, Emek medical center, Afula, Israel

Official's Role

Study Chair

Facility Information:

Facility Name

Haemek Medical Center

City

Afula

Country

Israel

Facility Name

The Nazareth hospital

City

Nazareth

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

12501070

Citation

Vayssiere C, Favre R, Audibert F, Chauvet MP, Gaucherand P, Tardif D, Grange G, Novoa A, Descamps P, Perdu M, Andrini E, Janse-Marec J, Maillard F, Nisand I. Cervical length and funneling at 22 and 27 weeks to predict spontaneous birth before 32 weeks in twin pregnancies: a French prospective multicenter study. Am J Obstet Gynecol. 2002 Dec;187(6):1596-604. doi: 10.1067/mob.2002.127380.

Results Reference

background

PubMed Identifier

11244660

Citation

Skentou C, Souka AP, To MS, Liao AW, Nicolaides KH. Prediction of preterm delivery in twins by cervical assessment at 23 weeks. Ultrasound Obstet Gynecol. 2001 Jan;17(1):7-10. doi: 10.1046/j.1469-0705.2001.00357.x.

Results Reference

background

PubMed Identifier

22284156

Citation

Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Klein K, Rode L, Soma-Pillay P, Fusey S, Cam C, Alfirevic Z, Hassan SS. Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol. 2012 Feb;206(2):124.e1-19. doi: 10.1016/j.ajog.2011.12.003. Epub 2011 Dec 11.

Results Reference

background

PubMed Identifier

17899571

Citation

DeFranco EA, O'Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S, Soma-Pillay P, Porter K, How H, Schakis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW. Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2007 Oct;30(5):697-705. doi: 10.1002/uog.5159.

Results Reference

background

PubMed Identifier

22882759

Citation

Serra V, Perales A, Meseguer J, Parrilla JJ, Lara C, Bellver J, Grifol R, Alcover I, Sala M, Martinez-Escoriza JC, Pellicer A. Increased doses of vaginal progesterone for the prevention of preterm birth in twin pregnancies: a randomised controlled double-blind multicentre trial. BJOG. 2013 Jan;120(1):50-7. doi: 10.1111/j.1471-0528.2012.03448.x. Epub 2012 Aug 13.

Results Reference

background

PubMed Identifier

23433324

Citation

Senat MV, Porcher R, Winer N, Vayssiere C, Deruelle P, Capelle M, Bretelle F, Perrotin F, Laurent Y, Connan L, Langer B, Mantel A, Azimi S, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie. Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial. Am J Obstet Gynecol. 2013 Mar;208(3):194.e1-8. doi: 10.1016/j.ajog.2013.01.032.

Results Reference

background

PubMed Identifier

16647922

Citation

To MS, Fonseca EB, Molina FS, Cacho AM, Nicolaides KH. Maternal characteristics and cervical length in the prediction of spontaneous early preterm delivery in twins. Am J Obstet Gynecol. 2006 May;194(5):1360-5. doi: 10.1016/j.ajog.2005.11.001. Epub 2006 Apr 21.

Results Reference

background

PubMed Identifier

21739497

Citation

Rode L, Klein K, Nicolaides KH, Krampl-Bettelheim E, Tabor A; PREDICT Group. Prevention of preterm delivery in twin gestations (PREDICT): a multicenter, randomized, placebo-controlled trial on the effect of vaginal micronized progesterone. Ultrasound Obstet Gynecol. 2011 Sep;38(3):272-80. doi: 10.1002/uog.9093.

Results Reference

background

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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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