Clinical trial NCT05727085: Cohort of Twin Pregnancy and the Offspring
Official title: Cohort of Twin Pregnancy and the Offspring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Twin Pregnancy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman with twin pregnancy and their offspring within 3 years old.

Brief summary: Twin pregnancy increases the risk of maternal and fetal complications, which include gestational hypertension, premature labor, twin-to-twin transfusion syndrome, intrauterine growth restriction, anemia, amniotic fluid abnormalities. Comprehensively understanding the molecular mechanisms of the disease and identification of markers contribute to development of novel therapeutic approaches. In addition, the twin pregnancy, especially the monochorionic, is an essential model of "experiments of nature". This model can be applied to distinguish the epigenetic differences of twins in utero and after birth in the same genomic context. The aim of the study is to constitute a prospective cohort of twin pregnancies and the offspring.

Detailed description: Data are collected regarding the pregnancy data of the mother, and mental, physical and sociodemographic information of the offspring. The periods span from diagnosis of twins to 3 years old of the offspring. Biological samples would be collected including maternal blood, placental tissues, cord blood, urine, and stool from the pregnant women or the offspring at the specific time.

The total estimated duration of the study is 6 years, of which the first 2.5 years will correspond to the recruitment period of the participants.

Eligibility criteria: Inclusion Criteria:

1. Maternal age \>18 years old.
2. Twin pregnancy.

Exclusion Criteria:

1. Fetal chromosomal or congenital abnormalities.
2. Stillbirth.

Primary outcomes:
measure: The incidence of maternal and fetal complications
timeFrame: From confirmation of pregnancy to 42 days postpartum
measure: RNA profiles in placentas of twin pregnancy measured by RNA-sequencing
timeFrame: Immediately after delivery
measure: Global DNA methylation in placentas of twin pregnancy measured by whole-genome bisulfite sequencing
timeFrame: Immediately after delivery
measure: Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification.
timeFrame: Immediately after delivery
measure: Post-translation modification of proteins in placentas of twin pregnancy measured by Integrative use of phosphoproteomics, ubiquitylproteomics and acetylproteomics.
timeFrame: Immediately after delivery
measure: Metabolite profiles in placentas of twin pregnancy measured by metabolomics
timeFrame: Immediately after delivery
measure: Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis
timeFrame: Immediately after delivery
measure: Predictive protein markers of maternal and fetal complications in maternal blood measured by tandem mass tags quantification
timeFrame: From confirmation of pregnancy to 42 days postpartum
measure: Predictive RNA markers of maternal and fetal complications in maternal blood measured by RNA-sequencing
timeFrame: From confirmation of pregnancy to 42 days postpartum
measure: Predictive metabolite markers of maternal and fetal complications in maternal blood measured by metabolomics
timeFrame: From confirmation of pregnancy to 42 days postpartum
measure: Predictive lipid markers of maternal and fetal complications in maternal blood measured by lipidomic analysis
timeFrame: From confirmation of pregnancy to 42 days postpartum
Secondary outcomes:
measure: The level of twin Neurodevelopment assessed by Gesell Developmental Schedules
timeFrame: Age at 3 years of the offspring
measure: The incidence of long term maternal complications
timeFrame: Three years after delivery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
Study officials:
References: