NCT02470676

Brief Summary

The purpose of this randomized control trial is to determine whether cervical pessary plus vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm delivery rate, and improving perinatal outcome, among women presenting with an asymptomatic mid-pregnancy short cervix, in singleton and twin gestations. All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24 completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed with cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to participate in the clinical trial. Women who meet eligible criteria will be invited to participate in the clinical trial. Women will be randomly assigned into one of the following groups: group A (vaginal progesterone) or group B (vaginal progesterone + pessary). Follow-up visits for ultrasound assessment of fetal growth and cervical length will be carried out every two weeks until 37 weeks of gestation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
430

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2015

Typical duration for phase_2

Status
unknown

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

June 4, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

June 4, 2015

Last Update Submit

June 9, 2015

Conditions

Preterm BirthShort Cervix

Outcome Measures

Primary Outcomes (2)

  • preterm birth before 34 weeks of gestation rate in singleton pregnancies

    up to 20 weeks from recruitment

  • preterm birth before 32 weeks of gestation rate in twin pregnancies

    up to 20 weeks from recruitment

Secondary Outcomes (3)

  • Other preterm birth age before 34, 28 weeks in twin pregnancies

    up to 20 weeks from recruitment

  • Neonatal/perinatal complications rate

    up to 20 weeks from recruitment

  • Maternal Adverse events

    up to 20 weeks from recruitment

Study Arms (2)

Progesterone

ACTIVE COMPARATOR

200 mg daily of vaginal progesterone suppositories (Utrogestan)

Drug: Progesterone

Progesterone plus Experimental device

EXPERIMENTAL

Experimental device + 200 mg daily progesterone vaginal suppositories (Utrogestan)

Device: Pessary

Interventions

PessaryDEVICE

Two optional pessary sizes with the following dimensions: 65/17/35 or 70/17/35 and 200 mg daily progesterone vaginal suppositories (Utrogestan)

Progesterone plus Experimental device
ProgesteroneDRUG

200 mg daily of vaginal progesterone suppositories (Utrogestan)

Progesterone

Eligibility Criteria

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

You may qualify if:

  • Diagnosed to be pregnant at up to 24+0 weeks of gestation, with a cervical length measurement of ≤25 mm with a singleton pregnancy, or ≤38 mm in twins pregnancy.

You may not qualify if:

  • Willingness to comply with the protocol for the duration of the study.
  • Have signed an informed consent.
  • Fetal factors: major fetal abnormalities, death of one or both of the fetuses, twins- twin-to-twin transfusion syndrome, and severe growth retardation.
  • Maternal factors: prophylactic cervical cerclage in situ, painful regular uterine contractions, active labor, active vaginal bleeding, maternal age under 18, uterine abnormalities (i.e. two cervices), and severe uterine prolapse.
  • Membranes and placental factors: placenta previa, ruptured membranes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2022 Dec 1;12(12):CD014508. doi: 10.1002/14651858.CD014508.

    PMID: 36453699DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

PessariesProgesterone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and SuppliesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Central Study Contacts

Asnat Walfisch, MD

CONTACT

+972 50 4492200asnatwalfisch@yahoo.com

Dvir Reder, MD

CONTACT

+972 52 6131383dvir.reder@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 12, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2019

Last Updated

June 12, 2015

Record last verified: 2015-06