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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Premature Labour

Intervention / Treatment
-----------------
* Drug: Progesterone
* Procedure: Cervical cerclage


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progesterone group<br>Vaginal progesterone suppositories will be given | Drug: Progesterone<br>* Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day<br>* Other names: Prontogest;|
| Active Comparator: Cerclage group<br>Cervical cerclage will be performed. | Procedure: Cervical cerclage<br>* 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)<br>* Other names: Cervical stitch;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm labor before 35 weeks |  | Up to 35 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery before 37 weeks |  | Up to 37 weeks gestational age | 
| Low birth weight (LBW) | Birth weight of a living neonate of < 2500 gm regardless of gestational age | At birth | 
| Neonatal respiratory distress syndrome (RDS) |  | At birth | 
| Early neonatal death (END) |  | One month after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm labor, Short cervix, Progesterone, Cervical cerclage