Effect of Glucose 5% on Labor Length

NCT04492150 | Unknown

• 1 other identifier: 4018
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of cesarean sections

  24 hours

Study Arms (2)

study group

EXPERIMENTAL

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; Drug: Saline

control group

ACTIVE COMPARATOR

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

Drug: Saline

Interventions

Dextrose 5%/Nacl 0.3% Inj_#3 DRUG

250 mL/hour of dextrose 5% intravenous drip

study group

Saline DRUG

250 mL/hour of normal saline intravenous drip

control group; study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez canal University

Ismailia, Egypt

RECRUITING

MeSH Terms

Interventions

Glucose; Sodium Chloride

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Zakia M Ibraheim, MD

  Professor of Gynecology and Obstetrics

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Salwa H Tammam, M. B. B. Ch

CONTACT

00201012869258; Dr.salwa.hussein.tammam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: September 9, 2019
• Primary Completion: September 10, 2020
• Study Completion: October 10, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)