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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04492150
Other study ID # 4018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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