Effect of Glucose 5% on Labor Length

Not Applicable

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

• Registration Number: NCT04492150
• Lead Sponsor: Suez Canal University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-09
• Status Verified: 2020-07
• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30
• Primary Completion: 2020-09-10
• Study Completion: 2020-10-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 476

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Dextrose 5%/Nacl 0.3% Inj_#3	women who will receive 250 mL/hour of dextrose 5% with normal saline in a 1:1 ratio.
study group	Saline	women who will receive 250 mL/hour of dextrose 5% with normal saline in a 1:1 ratio.
control group	Saline	women who will receive 250 mL/hour of normal saline for the whole duration of induction

Primary Outcome Measures

Name	Time	Method
the duration of labor	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Rate of cesarean sections	24 hours	the number of cases delivered by cesarean section

Trial Locations

Locations (1)

Suez canal University; 🇪🇬 Ismailia, Egypt