Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM

Premature Labour Clinical Trial

Official title:

Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02673359
• Other study ID #: WR2
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: January 2024

Study information

• Verified date: April 2023
• Source: Mansoura University
• Contact: Waleed El-refaie, Dr
• Email: wrefaie[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.

Description:

Women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (TVS) starting from 16 weeks till 24 weeks of gestation. Eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. At 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. For women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. For women in the cerclage group, McDonald cervical cerclage will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Women with singleton pregnancy.
• History of preterm labor and/or midtrimester miscarriage in a previous pregnancy.
• Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.

Exclusion Criteria:

• Age < 20 or > 35 years.
• Congenital uterine malformation.
• Multifetal pregnancy.
• Known major fetal structural or chromosomal abnormality.
• Known allergy or contraindication (relative or absolute) to progesterone therapy.
• Presence of contraindication to cervical cerclage.
• Medical conditions complicating pregnancy.
• Vaginal bleeding.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Labour

Intervention

Drug:
• Progesterone
Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day

Procedure:
• Cervical cerclage
Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)

Locations

Country	Name	City	State
Egypt	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansourah	Dakahlia
Egypt	Private practice settings	Mansourah	Dakahlia
Egypt	Obstetrics and Gynecology Department in Port Said University	Port Said

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Sayed Abdelhafez

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm labor before 35 weeks		Up to 35 weeks gestational age
Secondary	Delivery before 37 weeks		Up to 37 weeks gestational age
Secondary	Low birth weight (LBW)	Birth weight of a living neonate of < 2500 gm regardless of gestational age	At birth
Secondary	Neonatal respiratory distress syndrome (RDS)		At birth
Secondary	Early neonatal death (END)		One month after birth