Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix
ConditionPreterm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Hospital of Obstetrics and Gynecology
About this trial
This study aims to compare the effectiveness of cervical cerclage combined with progesterone versus progesterone alone in preventing preterm birth among women with twin pregnancies and a short cervix (cervical length ≤ 30 mm). Participants will be randomly allocated to either the intervention group (cerclage plus progesterone) or the control group (progesterone alone).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Maternal age ≥ 18
Twin pregnancy
Asymptomatic short cervix (CL≤30mm) at routine ultrasound investigation
Gestational age at 16+0- 24+0 weeks
Disqualifiers
Women with twin pregnancy in which one or both fetuses are diagnosed with a major structural or congenital abnormality that is likely to influence the composite adverse neonatal outcome.
Women with a monochorionic monoamniotic twin pregnancy
A monochorionic twin pregnancy with twin-to-twin transfusion syndrome before or at the time of inclusion.
Patients have indications for vaginal cerclage: Recurrent late miscarriage (from 14 weeks) or preterm birth occurring two or more times.
Trial design
Design model
Parallel
Treatments tested in this trial
Cervical cerclage
Procedure/SurgeryParticipants will receive cervical cerclage according to local protocols within one week after randomization. The procedure will be performed by two to three senior clinicians experienced in cerclage in each center, using the McDonald technique.
Progesterone
DrugVaginal micronized progesterone will be administered at a total daily dose of 400 mg, given as Utrogestan® 200 mg (Besins Healthcare, France) twice daily, in the morning and at bedtime. Participants will be asked to record their vaginal progesterone application in a patient diary sheet for up to 140 days.
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: Cerclage plus progesteroneExperimental treatment 2 interventions
Group B: Progesterone aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Preterm birth < 28 weeks
Number of participants with preterm birth before 28 weeks of gestation
Time frame
From randomization until 27 6/7 weeksSecondary outcomes
1
Gestational age at birth
Number of completed weeks and days of gestation at the time of delivery, calculated based on the date of embryo transfer for pregnancies conceived via in vitro fertilization (IVF), or by ultrasound measurement of the crown-rump length (CRL) of the larger fetus between 11 weeks and 13 weeks 6 days of gestation, or by head circumference measurement for pregnancies beyond 14 weeks of gestation.
Time frame
At birth2
Preterm birth < 32 weeks
Number of participants with preterm birth before 32 weeks of gestation
Time frame
From randomization until 31 6/7 weeks3
Preterm birth < 34 weeks
Number of participants with preterm birth before 34 weeks of gestation
Time frame
From randomization until 33 6/7 weeks4
Preterm birth < 37 weeks
Number of participants with preterm birth before 37 weeks of gestation
Time frame
From randomization until 36 6/7 weeksOther outcomes
1
Number of patients with TTTS after randomization
Number of patients diagnosed with twin-to-twin transfusion syndrome (TTTS) after randomization
Time frame
From randomization until delivery, assessed up to 28 days after delivery2
Number of participants diagnosed with TTTS after randomization who received treatment during the study period
Number of participants diagnosed with TTTS after randomization who received fetoscopic laser photocoagulation, serial amnioreduction, septostomy, selective reduction, or expectant management, from diagnosis until delivery
Time frame
From randomization until delivery, assessed up to 28 days after delivery3
Number of patients with preeclampsia
Number of patients diagnosed with preeclampsia
Time frame
From randomization until delivery, assessed up to 28 days after delivery4
Number of participants diagnosed with gestational diabetes mellitus (GDM) who required insulin therapy during the study period
Number of participants diagnosed with gestational diabetes mellitus (GDM) who required insulin therapy during the study period
Time frame
From randomization until delivery, assessed up to 28 days after deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
National Hospital of Obstetrics and Gynecology
Lead sponsor
Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam
Collaborator
Ninh Binh Obstetrics and Pediatrics Hospital, Ninh Binh, Vietnam
Collaborator
Bac Ninh 1 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam
Collaborator
Bac Ninh 2 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam
Collaborator
Hung Yen Obstetrics and Pediatrics Hospital, Hung Yen, Vietnam
Collaborator
Source ClinicalTrials.gov