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

Twin; Pregnancy, Affecting Fetus or Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03781466
• Other study ID #: aswu/190/18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2019
• Source: Aswan University Hospital
• Contact: hany f sallam, md
• Phone: 01022336052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Twin; Pregnancy, Affecting Fetus or Newborn

Intervention

Procedure:
• Cervical cerclage
Cervical cerclage indicated by short cervix =25mm

Drug:
• vaginal progesterone
Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm labor before 34 weeks	Number of patients with preterm birth before 34 weeks gestations	Up to 34 weeks gestational age
Secondary	Neonatal respiratory distress syndrome	number of neonatal respiratory distress syndrome	At birth
Secondary	Early neonatal death	number babies died in the neonatal period	within one month postpartum