Pessary Versus Progesterone in Singletons

NCT04300322 | Unknown DMC

• 1 other identifier: CS/BVMD/20/04
• Study Type: interventional
• Target: 804
• Locations: 1 country
• Sites: 3

Brief Summary

This study compares the effectiveness of cervical pessary to vaginal progesterone for prevention of preterm birth in women with singleton pregnancies and a cervix ≤25 mm. Participants will be randomly assigned in a 1:1 ratio to receive cervical pessary or vaginal progesterone.

Conditions

Preterm Birth; Short Cervix

Keywords

Preterm Birth; Singleton Pregnancies; Short Cervix; Pessary; Progesterone

Outcome Measures

Primary Outcomes (1)

• Rate of preterm birth <37 weeks of gestation by any cause

  Birth before 37 weeks

  From date of randomisation until 36 6/7 weeks

Secondary Outcomes (41)

• Gestational age at delivery

  At birth

• Time from randomization to delivery

  From date of randomisation until the date of delivery.

• Rate of preterm birth before 28 weeks of gestation

  From date of randomisation until 27 6/7 weeks

• Rate of preterm birth before 34 weeks of gestation

  From date of randomisation until 33 6/7 weeks

• Rate of spontaneous preterm birth <28 weeks

  From date of randomisation until 27 6/7 weeks

Study Arms (2)

Cervical pessary

ACTIVE COMPARATOR

Cervical pessary (Arabin) will be inserted to participants at 16-22 weeks and removed at 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.

Device: Cervical pessary

Vaginal Progesterone

ACTIVE COMPARATOR

Vaginal progesterone (Cyclogest 200 mg) once a day will be used, from 16-22 to 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.

Drug: Vaginal Progesterone

Interventions

Cervical pessary DEVICE

Arabin (cervical pessary) will be inserted at 16-22 weeks and removed at 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort

Also known as: Arabin

Cervical pessary

Vaginal Progesterone DRUG

Vaginal progesterone (Cyclogest 200 mg) once a day will be used, from 16-22 to 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.

Also known as: Cyclogest 200 mg

Vaginal Progesterone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancies
• Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0/7-22 0/7 weeks of gestation)
• Not participating in any other study which has intervention on maternity or fetus at the same time
• Provision of written informed consent to participate as shown by a signature on the patient consent form.

You may not qualify if:

• Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina
• Major congenital abnormalities of the fetus
• Presence of severe vaginal discharge
• Presence of vaginitis or cervicitis
• Presence of vaginal bleeding
• Preterm premature rupture of membranes
• Premature labor without ruptured membrane at the time of screening
• Suspected chorioamnionitis
• Unable to have cervical pessary inserted
• Cerclage or pessary in place

Sponsors & Collaborators

• Mỹ Đức Hospital: lead
• My Duc Phu Nhuan Hospital HCMC, Vietnam: collaborator
• Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam: collaborator

Study Sites (3)

My Duc Phu Nhuan Hospital

Ho Chi Minh City, Phu Nhuan, Vietnam

RECRUITING

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

RECRUITING

Quang Ninh Obstetrics and Pediatrics Hospital

Quang Ninh, Vietnam

RECRUITING

Related Publications (16)

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  PMID: 22682464 BACKGROUND

• Platt MJ. Outcomes in preterm infants. Public Health. 2014 May;128(5):399-403. doi: 10.1016/j.puhe.2014.03.010. Epub 2014 May 1.

  PMID: 24794180 BACKGROUND

• Lawn JE, Kinney MV, Belizan JM, Mason EM, McDougall L, Larson J, Lackritz E, Friberg IK, Howson CP; Born Too Soon Preterm Birth Action Group. Born too soon: accelerating actions for prevention and care of 15 million newborns born too soon. Reprod Health. 2013;10 Suppl 1(Suppl 1):S6. doi: 10.1186/1742-4755-10-S1-S6. Epub 2013 Nov 15.

  PMID: 24625252 BACKGROUND

• Vogel JP, Chawanpaiboon S, Moller AB, Watananirun K, Bonet M, Lumbiganon P. The global epidemiology of preterm birth. Best Pract Res Clin Obstet Gynaecol. 2018 Oct;52:3-12. doi: 10.1016/j.bpobgyn.2018.04.003. Epub 2018 Apr 26.

  PMID: 29779863 BACKGROUND

• Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; McIntosh J, Feltovich H, Berghella V, Manuck T. The role of routine cervical length screening in selected high- and low-risk women for preterm birth prevention. Am J Obstet Gynecol. 2016 Sep;215(3):B2-7. doi: 10.1016/j.ajog.2016.04.027. Epub 2016 Apr 28.

  PMID: 27133011 BACKGROUND

• Leung TN, Pang MW, Leung TY, Poon CF, Wong SM, Lau TK. Cervical length at 18-22 weeks of gestation for prediction of spontaneous preterm delivery in Hong Kong Chinese women. Ultrasound Obstet Gynecol. 2005 Dec;26(7):713-7. doi: 10.1002/uog.2617.

  PMID: 16308894 BACKGROUND

• 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.

  PMID: 22284156 BACKGROUND

• Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.

  PMID: 21472815 BACKGROUND

• Norman JE, Marlow N, Messow CM, Shennan A, Bennett PR, Thornton S, Robson SC, McConnachie A, Petrou S, Sebire NJ, Lavender T, Whyte S, Norrie J; OPPTIMUM study group. Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial. Lancet. 2016 May 21;387(10033):2106-2116. doi: 10.1016/S0140-6736(16)00350-0. Epub 2016 Feb 24.

  PMID: 26921136 BACKGROUND

• Romero R, Conde-Agudelo A, Da Fonseca E, O'Brien JM, Cetingoz E, Creasy GW, Hassan SS, Nicolaides KH. Vaginal progesterone for preventing preterm birth and adverse perinatal outcomes in singleton gestations with a short cervix: a meta-analysis of individual patient data. Am J Obstet Gynecol. 2018 Feb;218(2):161-180. doi: 10.1016/j.ajog.2017.11.576. Epub 2017 Nov 17.

  PMID: 29157866 BACKGROUND

• Arabin B, Halbesma JR, Vork F, Hubener M, van Eyck J. Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? J Perinat Med. 2003;31(2):122-33. doi: 10.1515/JPM.2003.017.

  PMID: 12747228 BACKGROUND

• Goya M, de la Calle M, Pratcorona L, Merced C, Rodo C, Munoz B, Juan M, Serrano A, Llurba E, Higueras T, Carreras E, Cabero L; PECEP-Twins Trial Group. Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins). Am J Obstet Gynecol. 2016 Feb;214(2):145-152. doi: 10.1016/j.ajog.2015.11.012. Epub 2015 Nov 25.

  PMID: 26627728 BACKGROUND

• Liem S, Schuit E, Hegeman M, Bais J, de Boer K, Bloemenkamp K, Brons J, Duvekot H, Bijvank BN, Franssen M, Gaugler I, de Graaf I, Oudijk M, Papatsonis D, Pernet P, Porath M, Scheepers L, Sikkema M, Sporken J, Visser H, van Wijngaarden W, Woiski M, van Pampus M, Mol BW, Bekedam D. Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial. Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5.

  PMID: 23924878 BACKGROUND

• Dang VQ, Nguyen LK, Pham TD, He YTN, Vu KN, Phan MTN, Le TQ, Le CH, Vuong LN, Mol BW. Pessary Compared With Vaginal Progesterone for the Prevention of Preterm Birth in Women With Twin Pregnancies and Cervical Length Less Than 38 mm: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):459-467. doi: 10.1097/AOG.0000000000003136.

  PMID: 30741812 BACKGROUND

• Jin Z, Chen L, Qiao D, Tiwari A, Jaunky CD, Sun B, Wang L, Yu H. Cervical pessary for preventing preterm birth: a meta-analysis. J Matern Fetal Neonatal Med. 2019 Apr;32(7):1148-1154. doi: 10.1080/14767058.2017.1401998. Epub 2017 Nov 20.

  PMID: 29103351 BACKGROUND

• Saccone G, Ciardulli A, Xodo S, Dugoff L, Ludmir J, Pagani G, Visentin S, Gizzo S, Volpe N, Maruotti GM, Rizzo G, Martinelli P, Berghella V. Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length: A Systematic Review and Meta-analysis. J Ultrasound Med. 2017 Aug;36(8):1535-1543. doi: 10.7863/ultra.16.08054. Epub 2017 Apr 11.

  PMID: 28398701 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Vinh Q Dang, MD

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vinh Q Dang, MD

CONTACT

+84908225481; bsvinh.dq@myduchospital.vn

Minh N Chau, MD

CONTACT

+84903119996; bsminh.cn@myduchospital.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised to either pessary or progesterone in a 1:1 ratio with a variable block size of 2, 4 or 6.

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 9, 2020
• Study Start: May 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

VN (3)