Effect of Fasting Time Before Cesarean Section on Neonatal Blood Glucose in Pregnant Women With Gestational Diabetes Mellitus

June 4, 2021 updated by: Second Affiliated Hospital of Wenzhou Medical University
Objective: To observe the effect of different fasting time on neonatal blood glucose in pregnant women with gestational diabetes mellitus (GDM). Methods: 122 pregnant women with gestational diabetes mellitus were selected from September 2018 to September 2020 in XX Hospital for regular prenatal examination, matching of pregnancy and delivery times, and undergoing elective lower uterine cesarean section to terminate pregnancy. The pregnant women were divided into 5 groups according to their fasting time before operation and whether they were given rehydration on the same day before operation, There were 27 cases in group B (fasting time 12.75 ± 0.48 hours, no rehydration before operation), 20 cases in group C (fasting time 15.65 ± 0.52 hours, no rehydration before operation), 24 cases in group D (fasting time 12.75 ± 0.48 hours, intravenous drip of 5% glucose sodium chloride 500ml at 8:00 on the day of operation), 24 cases in Group E (fasting time 15.65 ± 0.52 hours, intravenous drip of 5% glucose sodium chloride 500ml at 8:00 on the day of operation). The blood glucose of pregnant women within half an hour before operation, the blood glucose of newborns after delivery and the incidence of neonatal hypoglycemia were observed and recorded.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

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.
Observational

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.
300

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 to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant women

Description

Inclusion Criteria:

(1) The pregnant woman is born at term and has a single child; (2) Regular obstetric examination during pregnancy with complete obstetric examination data was diagnosed as gestational diabetes mellitus; (3) Pregnant women with body mass index (BMI) < 35kg/㎡; (4) All the operations were performed electively, and epidural anesthesia was used as the surgical anesthesia.

Exclusion Criteria:

(1) Pregnancy complicated with medical and surgical diseases, such as thyroid dysfunction and chronic hypertension; (2) Insufficiency of vital organ function or complicated tumor; (3) Pregnant women with other pregnancy complications besides GDM, such as preeclampsia, etc.; (4) The operation method is classical cesarean section or pregnant women with postpartum hemorrhage;

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
healthy pregnant woman
Other: Peripheral blood glucose levels were monitored
Peripheral blood glucose levels were monitored
pregnant women with GDM
pregnant women with gestational diabetes mellitus
Other: Peripheral blood glucose levels were monitored
Peripheral blood glucose levels were monitored

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
Measure Description
Time Frame
blood glucose concentration
Time Frame: 37 weeks to 40 weeks gestation
Peripheral blood glucose concentration of maternal fingers
37 weeks to 40 weeks gestation

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
blood glucose concentration
Time Frame: 37 weeks to 40 weeks gestation
Blood glucose concentration in the peripheral finger of the newborn
37 weeks to 40 weeks gestation

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.
Second Affiliated Hospital of Wenzhou Medical University

Study record dates

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Study Major Dates

Study Start (Anticipated)

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.
September 1, 2021

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.
December 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.
September 30, 2023

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).
June 4, 2021

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.
June 4, 2021

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.
June 7, 2021

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.
June 7, 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.
June 4, 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.
June 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.
  • SAHoWMU-CR2021-07-202

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

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