Effect of Glucose 5% on Labor Length

The Effect of Adding Parenteral Dextrose Solution During Induction of Labor on Total Labor Length Among Multiparous Women in Ismailia, Egypt: A Randomized Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Drug: Dextrose 5%/Nacl 0.3% Inj_#3; Drug: Saline

• Study Type: Interventional
• Enrollment (Anticipated): 476
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Recruiting
    • Suez Canal University
    • Contact: Salwa Hussein, MMBCh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: study group; women who will receive 250 mL/hour of dextrose 5% with normal saline in a 1:1 ratio.	Drug: Dextrose 5%/Nacl 0.3% Inj_#3; 250 mL/hour of dextrose 5% intravenous drip; Drug: Saline; 250 mL/hour of normal saline intravenous drip
ACTIVE_COMPARATOR: control group; women who will receive 250 mL/hour of normal saline for the whole duration of induction	Drug: Saline; 250 mL/hour of normal saline intravenous drip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the duration of labor	the duration from the beginning of active labor (cervical exam between 3 and 5 cm with regular uterine contractions) to fetal delivery, reported in minutes.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of cesarean sections	the number of cases delivered by cesarean section	24 hours

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Study Chair: Zakia M Ibraheim, MD, Professor of Gynecology and Obstetrics; Study Director: Mariam L Mohammed, MD, Assistant Professor of Gynecology and Obstetrics; Study Director: Hanan M Ghoneim, MD, Assistant Professor of Gynecology and Obstetrics; Study Director: Ahmed M Abbas, MD, Assistant Professor of Gynecology and Obstetrics

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2019
• Primary Completion (ANTICIPATED): September 10, 2020
• Study Completion (ANTICIPATED): October 10, 2020

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (ACTUAL): July 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 4018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No