Cervical pessary (Arabin) will be inserted to participants at 16-22 weeks and removed at 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.

Vaginal progesterone (Cyclogest 200 mg) once a day will be used, from 16-22 to 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.

Preterm Birth

Short Cervix

Arabin (cervical pessary) will be inserted at 16-22 weeks and removed at 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort

Cervical pessary

Vaginal Progesterone

My Duc Phu Nhuan Hospital

Mỹ Đức Hospital

Quang Ninh Obstetrics and Pediatrics Hospital

Pessary Versus Progesterone in Singletons (AP-Singletons)

The Effectiveness of Cervical Pessary Versus Vaginal Progesterone for the Prevention of Preterm Birth in Women With Singleton Pregnancies and Short Cervix: a Multicenter Randomized Controlled Trial

Time interval between randomisation and delivery

Birth spontaneously before 28 weeks' gestation, including preterm spontaneous rupture of membranes, preterm premature rupture of membranes (PPROM)

Birth spontaneously before 34 weeks' gestation, including preterm spontaneous rupture of membranes, preterm premature rupture of membranes (PPROM)

Birth spontaneously before 37 weeks' gestation, including preterm spontaneous rupture of membranes, preterm premature rupture of membranes (PPROM)

Birth non-spontaneously before 28 weeks' gestation

Birth non-spontaneously before 34 weeks' gestation

Birth non-spontaneously before 37 weeks' gestation

Spontaneous, labor induction, elective C-section

Vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor)

The birth of at least one newborn, regardless of gestational age, that exhibits any sign of life such as respiration, heartbeat, umbilical pulsation or movement of voluntary muscles

Use of any tocolytic drug to treat preterm labour

Use of antenatal corticosteroids to prevent respiratory distressed syndrome

Prelabour rupture of membranes and gestational age less than 37 weeks

Number of admission days for treatment of preterm labour

Any congenital anomalies detected in baby born

Apgar score at 5 minute after birth. 5-minute Apgar score of 7-10 as reassuring, a score of 4-6 as moderately abnormal, and a score of 0-3 as low in the term infant and late-preterm infant.

Apgar score at 5 minute after birth <7. An increased relative risk of cerebral palsy.

Admission to neonatal intensive care unit of baby

Death of newborn before discharge from nursery

Death of a live-born infant within the first 28 days of life after the due day

Intrauterine fetal death after 20 weeks of gestation, or neonatal death

Baby born with no signs of life at or after 20 weeks' gestation

Foetal or neonatal death, intraventricular haemorrhage, respiratory distress syndrome, necrotizing enterocolitis or neonatal sepsis

presence of tachypnoea >60/minute, sternal recession and expiratory grunting, need for supplemental oxygen, and a radiological picture of diffuse reticulogranular shadowing with an air bronchogram

Repeated neonatal cranial ultrasound by the neonatologist according to the guidelines on neuro-imaging described by de Vries et al

The combination of clinical signs and positive blood cultures

Including vaginal discharge, vaginal bleeding, vaginal infection (confirmed by vaginal discharge culture)

Evaluated by VAS numerical rating scale. Assessments with units on a Scale.

After pessary initial placement, requiring to reposition the pessary by any reasons

Including necrosis or rupture of the cervix, cervical laceration

My Duc Phu Nhuan Hospital HCMC, Vietnam

Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam

Participants will be randomised to either pessary or progesterone in a 1:1 ratio with a variable block size of 2, 4 or 6.

A soft, flexible, silicone pessary, purchased from the manufacturer (Arabin®, Dr Arabin GmbH & Co KG, Germany) will be inserted through the vagina, upward around the cervix by 4 senior clinicians, who had experienced with pessary used, within one week of randomisation. Size of the pessary will be determined at the time of speculum inspection.

Women will be receiving the cervical cerclage according to local protocol, within a week after randomisation. 3 senior clinicians who had experienced with cerclage, will perform cerclage, using Mc Donald technique, under spinal anaesthesia.

400 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 400mg, Actavis, United Kingdom), will be applied once daily at bedtime, starting from the day of randomisation, in addition to the pessary that has been placed. Participants will be asked to record their drug application in a patient diary sheet for up to 140 days.

400 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 400mg, Actavis, United Kingdom), will be applied once daily at bedtime, starting from the day of randomisation, in addition to the cerclage that has been placed. Participants will be asked to record their drug application in a patient diary sheet for up to 140 days.

Twin Pregnancy

A soft, flexible, silicone pessary (Arabin®, Dr Arabin GmbH & Co KG, Germany) will be inserted through the vagina, upward around the cervix.

Pessary

Cervical cerclage using Mc Donald technique, under anaesthesia

Cervical cerclage

Cyclogest® 400mg, Actavis, United Kingdom, applied once daily at bedtime

Vaginal progesterone

Dang Quang Vinh

Pessary Versus Cerclage With or Without Progesterone in Twins

The Effectiveness of Cervical Pessary Compared to Cervical Cerclage With or Without Vaginal Progesterone for the Prevention of Preterm Birth in Women With a Twin Pregnancy and a Short Cervix: a Two-by-two Factorial Randomised Clinical Trial

Gestational age at delivery Time from randomisation to delivery Delivery < 24 weeks, < 28 weeks, < 32 weeks and < 37 weeks of gestation Spontaneous preterm birth < 24 weeks, < 28 weeks, < 32 weeks and < 37 weeks of gestation Onset of labor: spontaneous, labor induction, elective C-section Mode of delivery: vaginal delivery, C-section All livebirths at any gestational age Use of tocolytic drugs Use of antenatal corticosteroids Use of magnesium sulfat for fetal neuroprotection Preterm prelabour rupture of membranes Length of maternal admission for preterm labor (days) Chorioamnionitis Marternal mortality

The presence of tachypnoea >60/minute, sternal recession and expiratory grunting, need for supplemental oxygen, and a radiological picture of diffuse reticulogranular shadowing with an air bronchogram

Baby born with no signs of life at or after 28 weeks' gestation

Including vaginal discharge, vaginal bleeding, vaginal infection (confirmed by vaginal discharge culture), vaginal pain (evaluated by VAS numerical rating scale), pessary repositioning and necrosis or rupture of the cervix, cervical laceration

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) and study protocol will be available, upon request from investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose to achieve aims in the approved proposal. Data will be available at the beginning 9 months and ending 36 months following article publication. Proposals should be directed to bsvinh.dq@myduchospital.vn. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.project-redcap.org/

Participants will be randomised to either cerclage, pessary, cerclage plus progesterone or pessary plus progesterone in a 1:1:1:1 ratio with a variable block size of 4 or 8.

arabin/hemorrhage

Pessary Versus Progesterone in Singletons (AP-Singletons)

Pessary Versus Cerclage With or Without Progesterone in Twins

Baz done ki pi konplè remèd fèy medsin te apiye nan syans