Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorPeking University Third Hospital

About this trial

Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China (ChiTwiMC) is supported by National Key Research and Development Program of China - Reproductive Health and Women's and Children's Health Protection Project. This project is funded by the Ministry of Science and Technology of China under grant number 2023YFC2705900. The ChiTwiMC cohort is led by Professor Wei Yuan from the Department of Gynecology and Obstetrics at Peking University Third Hospital.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Twin pregnancies

Female aged between 18-45 years

Gestational age is less than 14 weeks

Planning to receive prenatal healthcare and delivery service at the study hospital

Disqualifiers

Women with mental disorders or serious maternal illness that is not eligible to participate

Inability to provide informed consent

Pregnant women not registered in our hospital

Trial population

The ChiTwiMC is a prospective cohort that will enroll 2000 pregnant women aged 18-45 years and over from 9 large obstetrical centers of University-Affiliated Hospitals (Peking University Third Hospital; First Affiliated Hospital, Sun Yat-Sen University; Chongqing Medical University; Shengjing Hospital; Shanghai First Maternity and Infant Hospital; The First Affiliated Hospital of Anhui Medical University; International Peace Maternity and Child Health Hospital; The Second Hospital of Shandong University; Shandong Provincial Hospital). These hospitals located at 7 supercities (Beijing, Shanghai, Guangzhou, Shenyang, Jinan, Chongqing, and Hefei) of China. Pregnant women who are planning to receive prenatal healthcare and delivery in those hospitals are potential candidates for the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Rate of preterm delivery

Preterm delivery is defined as delivery between 28 and 37 gestational weeks.

Time frame
From inclusion to delivery
2

Rate of preeclampsia

Preeclampsia is defined as the condition occurring in pregnant women after 20 weeks of gestation, characterized by systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, accompanied by any of the following: a urinary protein quantification ≥0.3 g/24 h, or a urine protein/creatinine ratio ≥0.3, or random urine protein ≥ (+) (as a method of examination when protein quantification is not feasible). In the absence of proteinuria, the condition may still be diagnosed if there is involvement of any organ or system, including but not limited to critical organs such as the heart, lungs, liver, kidneys, or abnormalities in the hematological, digestive, or neurological systems, as well as complications affecting the placenta-fetus.

Time frame
From inclusion to delivery
3

Rate of twin-to-twin transfusion syndrome (TTTS)

TTTS is diagnosed in monochorionic diamniotic twin pregnancies when there is a discordance in amniotic fluid volumes, with one fetus exhibiting polyhydramnios and the other oligohydramnios. Specifically, before 20 weeks of gestation, the condition is diagnosed if one fetus (the recipient) has a deepest vertical pocket (DVP) of amniotic fluid ≥8cm, while the other fetus (the donor) has a DVP ≤2cm; after 20 weeks of gestation, the diagnosis is made if one fetus (the recipient) has a DVP ≥10cm, while the other fetus (the donor) has a DVP ≤2cm.

Time frame
From inclusion to delivery
4

Rate of selective fetal growth restriction (sFGR)

sFGR is diagnosed in monochorionic diamniotic twin pregnancies when one fetus has an estimated fetal weight below the 10th percentile for its gestational age, and there is a discrepancy of ≥25% in the estimated fetal weights between the two fetuses.

Time frame
From inclusion to delivery

Secondary outcomes

1

Rate of sleep disorders

Women's physiological and psychological changes during pregnancy will affect sleep, and the occurrence of bad sleep during pregnancy is more common. It is generally assessed by a sleep questionnaire.

Time frame
From inclusion to delivery
2

Rate of mental and phycological disorders

Maternal mental health is as important as physical health, and good maternal mental health helps to promote the physical and mental health of the baby, as well as their own physical condition and natural childbirth. The condition of pregnant women is generally assessed by psychiatric departments.

Time frame
From inclusion to delivery
3

Rate of single intrauterine fetal demise

The death of one fetus for twin pregnancy,the occurrence in the second and third trimesters of pregnancy has substantial adverse effects on surviving infants.

Time frame
From inclusion to delivery
4

Rate of gestational hypertension

Take two consecutive measurements on the same arm, the systolic blood pressure more than 140 mmHg and (or) the diastolic blood pressure more than 90 mmHg. High blood pressure may lead to severe complications such as preclampsia and clampsia.

Time frame
From inclusion to delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

Chongqing Medical University

Collaborator

Shengjing Hospital

Collaborator

Peking University

Collaborator

Nankai University

Collaborator

Shanghai First Maternity and Infant Hospital

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

International Peace Maternity and Child Health Hospital

Collaborator

The Second Hospital of Shandong University

Collaborator

Shandong Provincial Hospital

Collaborator