Capturing Early Events in Human Parturition

Parturition; Precipitate Clinical Trial

Official title:

Capturing Early Events in Human Parturition Based on Whole-transcriptome Analysis of Maternal Blood Before and After Spontaneous Onset of Labor at Term

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411745
• Other study ID #: 2015.659
• Status: Recruiting
• Start date: December 1, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Chinese University of Hong Kong
• Contact: Tak Yeung LEUNG, MD
• Phone: 852-35052806
• Email: tyleung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective observational study on normal singleton pregnant women who have no sign of labor at 40 weeks of gestation or pregnant women who admitted to hospital for any sign of labor at term, aiming to identify labor-associated markers.

Description:

The mechanisms that instigate human parturition have not been completely understood, though hypotheses such as 'functional progesterone withdrawal' and inflammatory signaling have been proposed. Researchers including our group have previously identified panels of genes which were differentially expressed between placentas obtained after spontaneous birth and those after elective cesarean delivery. However, such findings obtained after birth could only reflects the late changes in parturition. Similar findings in other gestational tissues, such as fetal membranes, amniotic fluids, myometrial biopsies are available, but these sample types cannot be readily collected until delivery. Thus, we propose to explore biomarkers in maternal blood with a view to developing any useful analytes for predicting labor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of labor are invited to join the study.

Exclusion Criteria:

• Any obstetric contraindications for undergoing labor or vaginal delivery (e.g. placenta previa, cephalo-pelvic disproportion, macrosomia, previous classical cesarean section or uterine tear, etc).
• Any maternal or fetal complications that require immediate or early delivery (e.g. pre-eclampsia, abruption placenta, fetal distress, rupture of membranes, in utero death, etc).
• Any maternal or fetal complications that make vaginal birth an unfavorable choice (e.g. fetal growth restriction, fetal compromise or distress, etc).
• Any conditions that are known to affect the onset of labor (e.g. anencephaly).

Related Conditions & MeSH terms

• Parturition; Precipitate

Intervention

Other:
• No intervention, observational study

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RNA gene expression	Peripheral blood samples will be taken for RNA gene expression	Between 36 and 41 weeks of gestation