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

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.

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

Study Design

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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

Drug Information available for: Progesterone

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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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)

Contacts and Locations

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

More Information

Publications:

Vayssière C, Favre R, Audibert F, Chauvet MP, Gaucherand P, Tardif D, Grangé 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.

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.

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. Review.

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.

Serra V, Perales A, Meseguer J, Parrilla JJ, Lara C, Bellver J, Grifol R, Alcover I, Sala M, Martínez-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.

Senat MV, Porcher R, Winer N, Vayssière 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 Obstétrique et Gynécologie. 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.

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. Epub 2006 Apr 21.

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.

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Responsible Party:	Noah Zafran, Senion physician OB-GYN, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT02329535
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

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