Effect of Glucose 5% on Labor Length

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04492150
• Other study ID #: 4018
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: October 10, 2020

Study information

• Verified date: July 2020
• Source: Suez Canal University
• Contact: Salwa H Tammam, M. B. B. Ch
• Phone: 00201012869258
• Email: Dr.salwa.hussein.tammam[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 476
• Est. completion date: October 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Drug:
• Dextrose 5%/Nacl 0.3% Inj_#3
250 mL/hour of dextrose 5% intravenous drip
• Saline
250 mL/hour of normal saline intravenous drip

Locations

Country	Name	City	State
Egypt	Suez canal University	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of cesarean sections	the number of cases delivered by cesarean section	24 hours