Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix

Effect of Cervical Cerclage With or Without Vaginal Progesterone Versus Vaginal Progesterone Alone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix: A Randomized Clinical Trial

The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Study Overview

• Status: Unknown
• Conditions: Twin; Pregnancy, Affecting Fetus or Newborn
• Intervention / Treatment: Procedure: Cervical cerclage; Drug: vaginal progesterone

Detailed Description

There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women pregnant in dichorionic twins.
• Transvaginal sonographic cervical length is <25 mm at 16-20 weeks gestational age.
• No symptoms, signs or other risk factors for preterm labor

Exclusion Criteria:

• Age < 18 years or > 45 years.
• Known allergy or contraindication (relative or absolute) to progesterone therapy.
• Monochorionic twins.
• Known major fetal structural or chromosomal abnormality.
• Intrauterine death of one fetus or death of both fetuses.
• Fetal reduction in the current pregnancy.
• Medical conditions that may lead to preterm delivery.
• Rupture of membranes.
• Vaginal bleeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Cervical cerclage; Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm	Procedure: Cervical cerclage; Cervical cerclage indicated by short cervix ≤25mm; Other Names: Active Comparator
ACTIVE_COMPARATOR: vaginal progesterone; Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks	Drug: vaginal progesterone; Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks; Other Names: Active Comparator
ACTIVE_COMPARATOR: Cervical cerclage plus vaginal progesterone; Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks	Procedure: Cervical cerclage; Cervical cerclage indicated by short cervix ≤25mm; Other Names: Active Comparator; Drug: vaginal progesterone; Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks; Other Names: Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm labor before 34 weeks	Number of patients with preterm birth before 34 weeks gestations	Up to 34 weeks gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal respiratory distress syndrome	number of neonatal respiratory distress syndrome	At birth
Early neonatal death	number babies died in the neonatal period	within one month postpartum

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (ACTUAL): December 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Preterm birth; Twin gestation; Vaginal progesterone; cervical cerclage
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: aswu/190/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No