NCT02623881

Brief Summary

To compare the effectiveness of cervical pessary (Arabin) and vaginal progesterone for preventing premature birth in twin pregnancies after IVF

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 4, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2017

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

1.7 years

First QC Date

November 30, 2015

Last Update Submit

December 21, 2017

Conditions

Pregnancy

Keywords

Cervical pessaryVaginal progesteroneTwinsPremature birth

Outcome Measures

Primary Outcomes (1)

  • Preterm birth before 34 weeks of gestation

    Birth before 34 weeks

    At birth

Secondary Outcomes (31)

  • Intrauterine death before 24 weeks of gestation

    From randomisation to 24 weeks

  • Stillbirth

    At birth

  • Delivery before 24 weeks of gestation

    At birth

  • Delivery before 28 weeks of gestation

    At birth

  • Delivery before 32 weeks of gestation

    At birth

  • +26 more secondary outcomes

Study Arms (2)

Cervical pessary

ACTIVE COMPARATOR

Cervical pessary (Arabin) will be inserted to participants at 16-22 weeks and removed at 36 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 400 mg) once a day will be used, from 16-22 to 36 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.

Drug: Vaginal progesterone

Interventions

Cervical pessaryDEVICE

Arabin (cervical pessary) will be inserted at 16-22 weeks and removed at 36 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 progesteroneDRUG

Vaginal progesterone (Cyclogest 400 mg) once a day will be used, from 16-22 to 36 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort

Also known as: Cyclogest 400mg
Vaginal Progesterone

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible for enrolment into this trial, each female subject must fulfil all of the following criteria at the start of enrolment, unless specified otherwise:
  • Women with a twin pregnancy (mono- and di-chorionic)
  • /7 to 22 0/7 weeks of gestation
  • Maternal age ≥ 18 yrs
  • Cervical length less than 38 mm
  • Informed consent
  • Not participating in another PTB study at the same time

You may not qualify if:

  • To be eligible for enrolment in this study each subject must not meet any of the following criteria:
  • History of cervical surgery
  • Cervical cerclage in place
  • Twin-to-twin transfusion syndrome
  • Stillbirth or major congenital abnormalities in any of the fetus
  • Severe vaginal discharge, acute vaginitis
  • Premature rupture of membranes
  • Premature labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, Tan Binh District, 70000, Vietnam

Location

Related Publications (1)

  • 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: 30741812DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Tuong M Ho, MD

    Research Center for Genetics and Reproductive Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 8, 2015

Study Start

March 4, 2016

Primary Completion

November 2, 2017

Study Completion

November 2, 2017

Last Updated

December 22, 2017

Record last verified: 2017-12

Locations

VN(1)