Capturing Early Events in Human Parturition

March 5, 2023 updated by: Tak Yeung LEUNG, Chinese University of Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Sha Tin, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parturition
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.
Other: No intervention, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RNA gene expression
Time Frame: Between 36 and 41 weeks of gestation
Peripheral blood samples will be taken for RNA gene expression
Between 36 and 41 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 5, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015.659

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parturition; Precipitate

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