Cervical Pessary vs. Vaginal Progesterone for Preventing Premature Birth in IVF Twin Pregnancies

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02623881
• Date of registration: 30/11/2015
• Prospective Registration: Yes
• Primary sponsor: Vietnam National University
• Public title: Cervical Pessary vs. Vaginal Progesterone for Preventing Premature Birth in IVF Twin Pregnancies
• Scientific title: The Effectiveness of Cervical Pessary Versus Vaginal Progesterone for Preventing Premature Birth in IVF Twin Pregnancies: a Randomized Controlled Trial.
• Date of first enrolment: March 4, 2016
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02623881
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Vietnam

Contacts

• Name: Tuong M Ho, MD
• Affiliation: Research Center for Genetics and Reproductive Health

Key inclusion & exclusion criteria

Inclusion Criteria:

To be eligible for enrolment into this trial, each female subject must fulfil all of the
following criteria at the start of enrolment, unless specified otherwise:

- Women with a twin pregnancy (mono- and di-chorionic)

- 16 0/7 to 22 0/7 weeks of gestation

- Maternal age = 18 yrs

- Cervical length less than 38 mm

- Informed consent

- Not participating in another PTB study at the same time

Exclusion Criteria:

To be eligible for enrolment in this study each subject must not meet any of the following
criteria:

- History of cervical surgery

- Cervical cerclage in place

- Twin-to-twin transfusion syndrome

- Stillbirth or major congenital abnormalities in any of the fetus

- Severe vaginal discharge, acute vaginitis

- Premature rupture of membranes

- Premature labor



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy

Intervention(s)

Device: Cervical pessary

Drug: Vaginal progesterone

Primary Outcome(s)

Preterm birth before 34 weeks of gestation [Time Frame: At birth]

Secondary Outcome(s)

5-minute Apgar score [Time Frame: At birth]

Admission days for preterm labor [Time Frame: From 24 weeks to 37 week]

Death before discharge [Time Frame: Up to 28 days after birth]

Maternal morbidity [Time Frame: From randomization to birth]

Bronchopulmonary dysplasia [Time Frame: At time of discharge home or at 36 weeks of gestational age]

Necrotising enterocolitis [Time Frame: Up to 28 days after birth]

Mode of delivery [Time Frame: At birth]

Use of tocolytics drug [Time Frame: From 24 weeks to 34 weeks]

Length of NICU admission [Time Frame: Up to 28 days after birth]

5-minute Apgar score < 7 [Time Frame: At birth]

Maternal side effects [Time Frame: From randomisation to birth]

Prelabour rupture of membrane [Time Frame: From randomization to less than 37 weeks]

Stillbirth [Time Frame: At birth]

Birthweight [Time Frame: At birth]

Birthweight < 1500g [Time Frame: At birth]

Delivery before 24 weeks of gestation [Time Frame: At birth]

Intrauterine death before 24 weeks of gestation [Time Frame: From randomisation to 24 weeks]

Proven sepsis [Time Frame: Up to 28 days after birth]

Severe respiratory distress syndrome [Time Frame: Within 24 hours after delivery]

Use of corticosteroids [Time Frame: From 24 weeks to 34 weeks]

Withdrawal from treatment [Time Frame: From randomization to 36 weeks of gestation]

Labour induction [Time Frame: At birth]

Admission to NICU [Time Frame: Within 7 days after delivery]

Congenital anomalies [Time Frame: At birth]

Delivery before 32 weeks of gestation [Time Frame: At birth]

Delivery before 37 weeks of gestation [Time Frame: At birth]

Intraventricular haemorrhage [Time Frame: Up to 28 days after birth]

Livebirth at any gestational age [Time Frame: At birth]

Birthweight < 2500g [Time Frame: At birth]

Choriamnionitis [Time Frame: From randomization to birth]

Delivery before 28 weeks of gestation [Time Frame: At birth]

Secondary ID(s)

NCKH/CGRH_10_2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

M? Ð?c Hospital