Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies
NCT Number: NCT06463652
Acronym: RESILIENT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Preterm Birth|Short Cervix
Interventions: PROCEDURE: Cervical cerclage|DRUG: Vaginal progesterone
Sponsor: Mỹ Đức Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 328
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-26
Completion Date: 2026-10
Locations: My Duc Hospital, Ho Chi Minh City, 70000, Vietnam

Summary:
This study compares the effectiveness of cervical cerclage with vaginal progesterone to vaginal progesterone only for the prevention of preterm birth in women with a singleton pregnancy and a short cervical length. Participants will be randomly assigned in a 1:1 ratio to receive cerclage plus progesterone or progesterone only.

Primary Outcome Measures: Time from randomization to delivery, Number of days between randomization and delivery, From date of randomization until the date of delivery
Secondary Outcome Measures: Composite poor neonatal outcomes (major sencondary endpoint), Stillbirth or neonatal death, intraventricular haemorrhage, respiratory distress syndrome, necrotizing enterocolitis or neonatal sepsis., From 20 weeks of gestation to 28 days after estimated due date|Miscarriage <22 weeks (late miscarriage), spontaneous loss of pregnancy between 12 to 22 weeks is termed as late miscarriage, From date of randomization to 22 weeks of gestation|Gestational age at delivery, Gestational age at delivery, At delivery|Preterm birth <24 weeks, <28 weeks, <32 weeks, <34 weeks and <37 weeks of gestation, Preterm birth is defined as any birth ≥ 22 and \< 37 completed weeks of gestation. Any birth \< 22 weeks is defined as late miscarriage, At delivery|Spontaneous preterm birth <24 weeks, <28 weeks, <32 weeks, <34 weeks and <37 weeks of gestation, Spontaneous preterm birth, including preterm labour, preterm spontaneous rupture of membranes, preterm premature rupture of membranes, and cervical weakness before 24 weeks, 28 weeks, 32 weeks, 34 weeks, and 37 weeks of gestation, respectively, does not include indicated preterm delivery for maternal or fetal conditions., At delivery|Iatrogenic preterm birth <24 weeks, <28 weeks, <32 weeks, <34 weeks and <37 weeks of gestation, Iatrogenic preterm birth, including planned delivery that occurs before 24 weeks, 28 weeks, 32 weeks, 34 weeks, and 37 weeks of gestation, respectively, due to maternal and/or fetal causes., At delivery|Onset of labor, Classified as spontaneous, labor induction, or elective C-section., At birth|Mode of delivery, Classified as vaginal delivery or C-section (elective, suspected fetal distress, non-progressive labor)., At birth|Live birth, Defined as the complete expulsion or extraction from a woman of a product of fertilization after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown, At birth|Use of tocolytic drugs, Use of any tocolytic drug to treat preterm labour, From 24 0/7 to 33 6/7 weeks' gestation|Use of Post cerclage antibiotics, Use of any treatment antibiotics after the cerclage procedure, Within one week after the cerclage procedure|Use of antenatal corticosteroids, Use of antenatal corticosteroids to prevent respiratory distressed syndrome, From 24 0/7 to 33 6/7 weeks' gestation|Use of MgSO4 for neuroprotection, Use of MgSO4 for neuroprotection, From 24 0/7 to 31 6/7 weeks' gestation|Fetal growth restriction, It is defined as the failure of the fetus to meet its growth potential due to a pathological factor, most commonly placental dysfunction., From randomization to delivery|Preterm premature rupture of membranes, When membrane rupture occurs before labor and before 37 weeks of gestation, From randomization to before 37 weeks of gestation|Length of maternal admission for labour, Number of maternal admission days for labour, Up to 2 weeks after birth|Total length of admission for threatened preterm labor, Number of admission days for treatment of preterm labour, From 22 0/7 to 36 6/7 weeks of gestation|Chorioamnionitis, Intraamniotic infection (diagnosed according to The American College of Obstetricians and Gynecologists Committee on Obstetric Practice No 712, 2017 (reaffirmed 2022)), From randomization to delivery|Maternal mortality, female deaths from any cause related to or aggravated by pregnancy or its management (excluding accidental or incidental causes) during pregnancy and childbirth or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, From randomization to during pregnancy and childbirth or within 42 days of termination of pregnancy|Maternal side effects, Vaginal discharge, vaginal bleeding, vaginal infection (confirmed by vaginal discharge culture), preterm premature rupture of membranes, chorioamnionitis, necrosis or rupture of the cervix, cervical laceration, vaginal or bladder injury., From date of randomization until delivery|Birthweight, Weight of the newborn measured right after delivery, At birth|Birthweight <1500 g, Weight of the newborn \<1500g, At birth|Birthweight <2500 g, Weight of the newborn \<2500g, At birth|Congenital anomalies, Structural or functional disorders that occur during intra-uterine life and can be identified prenatally and at birth. Congenital anomalies can be caused by single gene defects, chromosomal disorders, multifactorial inheritance, environmental teratogens, and micronutrient deficiencies. The time of identification will be reported., After randomization to at birth|1-min Apgar score, Apgar score at 1 minute after birth, 1 min after birth|5-min Apgar score, Apgar score at 5 minute after birth, 5 min after birth|Admission to neonatal intensive care unit, Admission to neonatal intensive care unit of baby, At birth and up to 28 days after birth|Length of stay in the neonatal intensive care unit, Number of admission days to neonatal intensive care unit, Up to 28 days after estimated due date|Neonatal death, Death of a live-born baby within 28 days of birth, Within the first 28 days of life after delivery|All stillbirth, Defined as the death of a fetus prior to the complete expulsion or extraction from its mother after 20 completed weeks of gestational age. The death is determined by the fact that, after such separation, the fetus does not breathe or show any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles. It includes deaths occurring during labor.

All stillbirth will be defined as a baby born with no signs of life at ≥ 20 weeks of gestation, After 20 weeks of gestation|Early stillbirth, A baby born with no signs of life at ≥ 20 weeks and \< 28 weeks of gestation, ≥ 20 weeks and < 28 weeks of gestation|Late stillbirth, A baby born with no signs of life at ≥ 28 weeks of gestation, After 28 weeks of gestation|Perinatal death, Either stillbirth or neonatal death, From 20 weeks of gestation to the first 28 days of life after delivery|Respiratory distress syndrome, Diagnosed as 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, Up to 28 days after estimated due date|Intraventricular haemorrhage II B or worse, Diagnosed by repeated neonatal cranial ultrasound by the neonatologist according to the guidelines on neuro-imaging described by de Vries et al, Up to 28 days after estimated due date|Necrotizing enterocolitis, An acquired gastrointestinal disease associated with significant morbidity and mortality in prematurely born neonates. Necrotizing enterocolitis will be diagnosed according to Bell et al., 1978, Up to 28 days after estimated due date|Neonatal sepsis, Diagnosed on the combination of clinical signs and positive blood cultures of the newborn, Up to 28 days after estimated due date