Effect of Glucose 5% on Labor Length

NCT ID: NCT04492150

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 476 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2020-10-10

Brief Summary

Induction of labor, is one of the most common obstetric procedures done routinely in modern obstetrics. For example, in USA, 23% of pregnant women in 2012 (about 1 million) underwent an induction of labor. However, accurate data about percentage of women undergoing induction of labor in Egypt is not accurately known.

One of the recent research era in current obstetrics is the optimal intravenous (IV) hydration of the pregnant women in labor.Current evidences available in our hands, suggest that maternal hydration appears to fasten labor progress and enhance the action of oxytocin, if the later is used for augmentation. However, the addition of glucose supplementation to this IV hydration to enhance uterine contraction, as a matter of safety and efficacy, is controversial

Conditions

Induction of Labor Affected Fetus / Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

study group

women who will receive 250 mL/hour of dextrose 5% with normal saline in a 1:1 ratio.

Group Type: EXPERIMENTAL

Dextrose 5%/Nacl 0.3% Inj_#3

Intervention Type: DRUG

250 mL/hour of dextrose 5% intravenous drip

Saline

Intervention Type: DRUG

250 mL/hour of normal saline intravenous drip

control group

women who will receive 250 mL/hour of normal saline for the whole duration of induction

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: DRUG

250 mL/hour of normal saline intravenous drip

Interventions

Dextrose 5%/Nacl 0.3% Inj_#3

250 mL/hour of dextrose 5% intravenous drip

Intervention Type: DRUG

Saline

250 mL/hour of normal saline intravenous drip

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult (>18 years) multiparous women
• Late Term Pregnancy ( gestational Age Between 40-42 weeks)
• Uncomplicated singleton pregnancy with cephalic presentation.
• Favorable cervix for induction (Bishop score<6) without ruptured membranes.

Exclusion Criteria

• Women with chronic diseases or complicated pregnancy; gestational and pre gestational ( type 1 & 2)diabetes, preeclampsia and\or renal and\or maternal heart diseases.
• Non-cephalic presentations, multiple pregnancies, or cervix unfavorable for induction.
• Other indications for cesarean delivery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Salwa Hussein Ismaeil Tammam

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zakia M Ibraheim, MD

Role: STUDY_CHAIR

Professor of Gynecology and Obstetrics

Mariam L Mohammed, MD

Role: STUDY_DIRECTOR

Assistant Professor of Gynecology and Obstetrics

Hanan M Ghoneim, MD

Role: STUDY_DIRECTOR

Assistant Professor of Gynecology and Obstetrics

Ahmed M Abbas, MD

Role: STUDY_DIRECTOR

Assistant Professor of Gynecology and Obstetrics

Locations

Suez canal University

Ismailia, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Salwa H Tammam, M. B. B. Ch

Role: CONTACT

Dr.salwa.hussein.tammam@gmail.com

00201012869258

Facility Contacts

Salwa Hussein, MMBCh

Role: primary

Other Identifiers

4018

Identifier Type: -

Identifier Source: org_study_id