The Best Timing of Delivery in Women With GDM Study

September 23, 2021 updated by: Wang Chen, Peking University First Hospital

The Best Timing of Delivery in Women With GDM That is Controlled With Only Diet and Exercise

The investigatiors aimed to conduct a well-designed RCT to firstly focus on GDM women controlled with only diet and exercise, and provide an optimize process on their timing and mode of delivery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

GDM is a common complication of pregnancy and even mildly hyperglycemia could significantly affect fetal growth. Optimal delivery timing in women with GDM remains controversial. This decision process involves balancing the potential for complications that are caused by increased interventions with the benefit of avoidance of future adverse outcomes. Thus, the aim of the present trial is to explore the best management on the timing of delivery of pregnant women with GDM that controlled with only diet and exercise, which can both decrease the risk of macrosomia and the risk of cesarean delivery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton pregnant women
  • in vertex presentation
  • GDM that is controlled with only diet and exercise
  • at 37 weeks 0 days to 37 weeks 6 days of gestation
  • more than 18 years old
  • have no other contraindications to vaginal delivery.

Exclusion Criteria:

  • prior caesarean section or myomectomy
  • any known contraindications to vaginal delivery
  • uncertain gestational age
  • non reassuring foetal wellbeing necessitating delivery
  • maternal pregnancy-related disease necessitating delivery (any hypertensive disorder, cardiac disease, renal insufficiency、immune diseases, et al.)
  • placenta previa, accreta, vasa previa
  • known foetal anomaly
  • negative reproductive history
  • ruptured membranes or known oligohydramnios (defined as AFI < 5 or MVP < 2 ) before 37weeks 6 days of gestation
  • fetal growth restriction, defined as EFW < 10th percentile
  • known HIV positivity because of modified delivery plan
  • signs of labor (regular painful contractions with cervical change) before 37weeks 6 days of gestation.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: old guideline group
Women randomized to the "old guideline group" will be followed up once-weekly by electronic fetal heart rate monitoring and biophysical profile until 40 weeks 0 days (unless a medical indication arises), when induction of labor was then offered.
Experimental: new procedure group
Women randomized to "new procedure group" will first undergo fetal weight ultrasound estimation at 38 weeks 0 days to 38 weeks 6 days of gestation, if the fetus is estimated to be LGA/macrosomia by ultrasound, women should have an elective induction of labor immediately (at 38 weeks 0 days to 38 weeks 6 days of gestation). On the contrary, if the fetus is estimated to be normal size, the pregnant women were then given a cervical assessment. If the Bishop score ≥6, women will have at least weekly follow-up visits with their doctors and unless a medical indication is present, continue pregnancy and have selective induction at 40 weeks 0 days of gestation. Whereas, if the Bishop score <6, women will be followed up until 41 weeks 0 days of gestation with a close assessment of fetal wellbeing through the cardiotocographic trace. And women who will not deliver by this gestational age will be admitted for labor induction. Certainly, medical indication should warrant delivery without delay.
Procedure: New procedure
An optimal management on the timing and mode of delivery of pregnant women with GDM, by a comprehensive assessment and consideration of their fetal weight, gestational age, and cervical ripeness.
Other Names:
  • New

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
caesarean section rate
Time Frame: 41weeks
41weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mode of delivery
Time Frame: 41weeks
spontaneous or operative vaginal delivery, caesarean section；the investigator will use questionnaire to collect these information from their medical record
41weeks
onset of labour
Time Frame: 41weeks
spontaneous or instrumental third stage of labour, planned or emergency caesarean section;the investigator will use questionnaire to collect these information
41weeks
operative vaginal delivery indication
Time Frame: 41weeks
chorioamnionitis defined as a clinical diagnosis before delivery; fetal distress; arrest of second stage of labour; maternal complicatio;the investigator will use questionnaire to collect these information from their medical record
41weeks
caesarean section indication
Time Frame: 41weeks
induction failed; chorioamnionitis defined as a clinical diagnosis before delivery; fetal distress; arrest of second stage of labour; failed instrumental delivery; maternal complication; elective
41weeks
method of induction of labour
Time Frame: 41weeks
prostaglandin tablet regime; artificial rupture of amniotic membranes; oxytocin exclusive if used to accelerate normal labour
41weeks
indication for induction
Time Frame: 41weeks
randomised to treatment; prelabour rupture of membranes > 2 hours and no regular contractions; fetal growth restriction; reduced fetal movements/suspected fetal distress; pregnancy induced hypertension; pre-eclampsia/eclampsia; obstetric cholestasis;the investigator will use questionnaire to collect these information from their medical record
41weeks
gestational age
Time Frame: 41weeks
41weeks
intrapartum complications
Time Frame: 41weeks
placental abruption; cord prolapse; postpartum haemorrhage defined as bleeding of 500/1000ml or more in the first 24 hours following the vaginal/ caesarean section delivery of the baby; third or fourth degree perineal laceration; admission to intensive care unit; hysterectomy; maternal venous thromboembolism
41weeks
birth weight
Time Frame: 41weeks
41weeks
neonatal sex
Time Frame: 41weeks
41weeks
neonatal plasma glucose level collected 1-2h after delivery
Time Frame: 41weeks
41weeks
neonatal hypoglycemia
Time Frame: 41weeks
41weeks
stillbirth
Time Frame: 41weeks
a baby delivered with no signs of life after24 completed weeks of pregnancy
41weeks
shoulder dystocia
Time Frame: 41weeks
the investigator will use questionnaire to collect these information from their medical record
41weeks
death before discharge from hospital
Time Frame: 41weeks
41weeks
Apgar at 1 min, Apgar at 5 min, Apgar at 10 minutes
Time Frame: 41weeks
41weeks
cord blood artery pH
Time Frame: 41weeks
41weeks
neonatal respiratory distress
Time Frame: 41weeks
the investigator will use questionnaire to collect these information from their medical record
41weeks
birth trauma
Time Frame: 41weeks
subdural haematoma, intracerebral or intraventricular haemorrhage, spinal-cord injury, basal skull fracture, peripheral-nerve injury, long bone fracture
41weeks
NICU admission
Time Frame: 41weeks
41weeks
seizures
Time Frame: 41weeks
the investigator will use questionnaire to collect these information from their medical record
41weeks
hypotonia
Time Frame: 41weeks
the investigator will use questionnaire to collect these information from their medical record
41weeks
intubation and ventilation for > 24 h
Time Frame: 41weeks
41weeks
oxygen required
Time Frame: 41weeks
41weeks
the utilization of medical resources
Time Frame: 41weeks
That includes: number of clinic visits post randomization to admission for delivery, number of times for having non-stress tests, ultrasounds and contraction stress tests, Use of induction and ripening agents, maximum dose of oxytocin, interval from randomization to delivery, number of hours on the labor and delivery unit, maternal postpartum length of hospital stay, neonatal length of hospital stay
41weeks
the mothers' expectations and experience of childbirth
Time Frame: 41weeks
measured by the Labour Agentry Scale (which is designed to assess the expectations and experiences of personal control during childbirth, with higher scores indicating greater perceived control during childbirth)
41weeks
rate of labor pain
Time Frame: 41weeks
41weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University First Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PekingUFHIOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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