Pessary Versus Cerclage With or Without Progesterone in Twins

NCT03863613 | Terminated DMC

• 1 other identifier: CS/MD/19/01
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone for prevention of preterm birth in women with a twin pregnancy and a cervix ≤28 mm. Participants will be randomly assigned in a 1:1:1:1 ratio to receive cerclage, pessary, cerclage plus progesterone or pessary plus progesterone.

Conditions

Preterm Birth; Twin Pregnancy; Short Cervix

Keywords

Pessary, Cerclage, Progesterone, Twins, Preterm birth

Outcome Measures

Primary Outcomes (1)

• Preterm birth <34 weeks

  Birth before 34 weeks' gestation

  From date of randomisation until 33 6/7 weeks

Secondary Outcomes (37)

• Gestational age at delivery

  At birth

• Time from randomisation to delivery

  From date of randomisation until the date of delivery, assessed up to 22 weeks

• Preterm birth <28 weeks

  From date of randomisation until 27 6/7 weeks

• Preterm birth <37 weeks

  From date of randomisation until 36 6/7 weeks

• Spontaneous preterm birth <28 weeks

  From date of randomisation until 27 6/7 weeks

Study Arms (4)

Pessary group

ACTIVE COMPARATOR

A soft, flexible, silicone pessary, purchased from the manufacturer (Arabin®, Dr Arabin GmbH \& Co KG, Germany) will be inserted through the vagina, upward around the cervix by 4 senior clinicians, who had experienced with pessary used, within one week of randomisation. Size of the pessary will be determined at the time of speculum inspection.

Device: Pessary

Cerclage group

ACTIVE COMPARATOR

Women will be receiving the cervical cerclage according to local protocol, within a week after randomisation. 3 senior clinicians who had experienced with cerclage, will perform cerclage, using Mc Donald technique, under spinal anaesthesia.

Procedure: Cervical cerclage

Pessary plus progesterone group

ACTIVE COMPARATOR

400 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 400mg, Actavis, United Kingdom), will be applied once daily at bedtime, starting from the day of randomisation, in addition to the pessary that has been placed. Participants will be asked to record their drug application in a patient diary sheet for up to 140 days.

Device: Pessary; Drug: Vaginal progesterone

Cerclage plus progesterone group

ACTIVE COMPARATOR

400 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 400mg, Actavis, United Kingdom), will be applied once daily at bedtime, starting from the day of randomisation, in addition to the cerclage that has been placed. Participants will be asked to record their drug application in a patient diary sheet for up to 140 days.

Procedure: Cervical cerclage; Drug: Vaginal progesterone

Interventions

Pessary DEVICE

A soft, flexible, silicone pessary (Arabin®, Dr Arabin GmbH \& Co KG, Germany) will be inserted through the vagina, upward around the cervix.

Also known as: Arabin

Pessary group; Pessary plus progesterone group

Cervical cerclage PROCEDURE

Cervical cerclage using Mc Donald technique, under anaesthesia

Also known as: Stitch

Cerclage group; Cerclage plus progesterone group

Vaginal progesterone DRUG

Cyclogest® 400mg, Actavis, United Kingdom, applied once daily at bedtime

Also known as: Cyclogest 200 mg

Cerclage plus progesterone group; Pessary plus progesterone group

Eligibility Criteria

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

You may qualify if:

• Women with a twin pregnancy (mono- and di-chorionic)
• /7 to 22 0/7 weeks of gestation
• Maternal age ≥18 yrs
• Cervical length ≤28 mm
• Informed consent
• Not participating in another preterm birth study at the same time

You may not qualify if:

• Uterine anomalies
• Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina
• Twin-to-twin transfusion syndrome
• Stillbirth or major congenital abnormalities in any of the fetus
• Severe vaginal discharge
• Acute vaginitis or cervicitis
• Vaginal bleeding
• Placental preavia
• Vasa preavia
• Premature rupture of membranes
• Premature labor with/without ruptured membrane
• Suspicion of chorioamnionitis
• Cerclage or pessary in place or unable to undergo cervical cerclage or pessary

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

My Duc Phu Nhuan Hospital

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (2)

• He YTN, Pham HNH, Nguyen TC, Bui TQ, Vuong NT, Nguyen DTN, Le TV, Li W, Le CH, Ho TM, Mol BW, Dang VQ, Vuong LN. Cervical cerclage versus cervical pessary with or without vaginal progesterone for preterm birth prevention in twin pregnancies and a short cervix: A two-by-two factorial randomised clinical trial. PLoS Med. 2025 Feb 21;22(2):e1004526. doi: 10.1371/journal.pmed.1004526. eCollection 2025 Feb.

  PMID: 39982935 DERIVED

• Dang VQ, He YT, Pham HN, Trieu TT, Bui TQ, Vuong NT, Nguyen LM, Nguyen DT, Le TV, Li W, Le CH, Mol BW, Vuong LN. Effectiveness of cervical pessary compared to cervical cerclage with or without vaginal progesterone for the prevention of preterm birth in women with twin pregnancies and a short cervix: study protocol for a two-by-two factorial randomised clinical trial. BMJ Open. 2020 Jun 16;10(6):e036587. doi: 10.1136/bmjopen-2019-036587.

  PMID: 32554744 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Pessaries; Cerclage, Cervical; Progesterone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Obstetric Surgical Procedures; Surgical Procedures, Operative; 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

• Yen TN He, MD

  My Duc Phu Nhuan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants will be randomised to either cerclage, pessary, cerclage plus progesterone or pessary plus progesterone in a 1:1:1:1 ratio with a variable block size of 4 or 8.

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 5, 2019
• Study Start: March 23, 2019
• Primary Completion: July 8, 2023
• Study Completion: July 29, 2023
• Last Updated: February 20, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available at the beginning 9 months and ending 36 months following article publication.
• Access Criteria: To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.project-redcap.org/.

Locations

VN (1)