Centile charts of cervical length in singleton and twin pregnancies between 16 and 24 weeks of gestation.
Bertan Akar, Yasin Ceylan, Alper Kahraman...
https://pubmed.ncbi.nlm.nih.gov/36999666Actively Recruiting
Led by National Hospital of Obstetrics and Gynecology · Updated on 2026-04-24
260
Participants Needed
6
Research Sites
21 weeks
Total Duration
N
National Hospital of Obstetrics and Gynecology
Lead Sponsor
Q
Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam
Collaborating Sponsor
Researchers are studying the prevention of preterm birth in women with twin pregnancies who have a short cervix measuring 30 mm or less. The trial aims to compare the effects of combining cervical cerclage with vaginal progesterone versus using vaginal progesterone alone. This condition is important because twin pregnancies carry a higher risk of early birth, which can lead to serious health issues for newborns, including complications affecting vital organs and long-term developmental problems. Participants are randomly assigned to one of two groups: one group will receive a cervical cerclage procedure plus vaginal progesterone, while the other group will receive vaginal progesterone alone. The cerclage involves placing a suture around the cervix before 24 weeks of pregnancy under spinal anesthesia. Vaginal progesterone is given twice daily until 37 weeks of pregnancy or delivery. The procedure is performed by trained obstetricians, and participants record their progesterone use in a diary to track adherence. During the study, participants will have follow-up visits every one to two weeks until delivery. These visits include routine antenatal care, cervical length measurement, and checks for any complications or side effects. Researchers will monitor outcomes such as the timing of birth before 28 weeks, other preterm birth milestones, maternal and neonatal health, and hospital costs. Data will also be collected from medical records if delivery occurs outside the study centers. The trial follows participants from randomization until delivery and postpartum periods as specified.
CONDITIONS
Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for cervical length measurement between 16 and 24 weeks of gestation
Duration - From randomization until 37 weeks of gestation or preterm birth, whichever comes first
Participants receive either cervical cerclage plus vaginal progesterone or vaginal progesterone alone to prevent preterm birth in twin pregnancies with a short cervix.
Initial treatment within one week after randomization; then follow-up visits every 2 weeks until delivery
Duration - From 7 days after randomization until delivery
Participants are monitored with routine antenatal care, cervical length measurements, and assessment of treatment compliance and any adverse events until delivery.
Visits 7 days after randomization and then every 2 weeks until delivery
Total: 6 locations
1
Bac Ninh 1 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam
Bac Ninh, Vietnam, 220000
Not Yet Recruiting
2
Bac Ninh 2 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam
Bac Ninh, Vietnam, 220000
Not Yet Recruiting
3
National Hospital of Obstetrics and Gynecology
Hanoi, Vietnam, 100000
Actively Recruiting
4
Hung Yen Obstetrics and Pediatrics Hospital, Hung Yen, Vietnam
Hung Yen, Vietnam, 160000
Not Yet Recruiting
5
Ninh Binh Obstetrics and Pediatrics Hospital, Ninh Binh, Vietnam
Ninh Binh, Vietnam, 430000
Not Yet Recruiting
6
Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam
Quang Ninh, Vietnam, 200000
Not Yet Recruiting
T
Thu Ha T Nguyen, Assoc. Prof
V
Viet C Dang, MD, MsC
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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