NCT02601443

Brief Summary

The incidence of multiple gestations has increased over the past years, mostly because of increased use of assisted reproductive technologies. Triplet pregnancies are at increased risk of preterm birth (PTB), which is the primary reason for their increased morbidity and mortality compared to singletons. Multiple gestations, including triplets, account for about 3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very low birth weight infants, and nearly 20% of infant mortality. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a short CL \<25mm before 24weeks, cerclage is associated with significant decreases in PTB and perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the contrary, the effect of cerclage in multiple gesttations has been insufficiently studied, with meta-analysis data showing a possible harm from cerclage compared to controls. The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in unselected triplet gestations. We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU CL \<30 mm)

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

4.1 years

First QC Date

November 9, 2015

Last Update Submit

November 15, 2018

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • Preterm delivery

    Less than 34 weeks gestation

Secondary Outcomes (12)

  • Gestational age at delivery

    Time of delivery

  • Birth weight

    Time of delivery

  • pontaneous preterm birth rates

    Less than 24, 28, 34 and 37 weeks gestation

  • Spontaneous rupture of membranes

    Less than 34 weeks gestation

  • Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery

    Time of delivery

  • +7 more secondary outcomes

Study Arms (2)

Cervical Pessary

EXPERIMENTAL

Cervical pessary is a medical device used to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early). Early in the pregnancy a round silicone pessary is placed at the opening to the cervix to close it, and then remove late in the pregnancy when the risk of a preterm birth has passed. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.

Device: Cervical Pessary

Routine care (watch and wait)

NO INTERVENTION

Interventions

Cervical PessaryDEVICE
Cervical Pessary

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Triplet pregnancy (limits the participants to female gender)
  • Gestational age at randomization between 20(0) and 22(6)

You may not qualify if:

  • Singleton, twin or higher order than triplets multiple gestation
  • Twin twin transfusion syndrome
  • Ruptured membranes
  • Lethal fetal structural anomaly
  • Fetal chromosomal abnormality
  • Cerclage in place (or planned placement)
  • Vaginal bleeding
  • Suspicion of chorioamnionitis
  • Ballooning of membranes outside the cervix into the vagina
  • Painful regular uterine contractions
  • Labor
  • Placenta previa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriele Saccone

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 10, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations

IT(1)