Induction of Labor Affected Fetus / NewbornNCT04492150
Effect of Glucose 5% on Labor Length
A study testing Dextrose 5%/Nacl 0.3% Inj_#3 and Saline in people with Induction of Labor Affected Fetus / Newborn, run by Suez Canal University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Dextrose 5%/Nacl 0.3% Inj_#3 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2019to 10 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Suez canal University
Ismailia
Salwa Hussein, MMBCh
About this study
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
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
- Being tested
- Dextrose 5%/Nacl 0.3% Inj_#3, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose 5%/Nacl 0.3% Inj_#3Drug
250 mL/hour of dextrose 5% intravenous drip
SalineDrug
250 mL/hour of normal saline intravenous drip
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | women who will receive 250 mL/hour of dextrose 5% with normal saline in a 1:1 ratio. Receives: 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 Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
Rate of cesarean sections
the number of cases delivered by cesarean section
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start9 Sep 2019
- Primary completion10 Sep 2020 (estimated)
- Study completion10 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salwa Hussein Ismaeil Tammam, Suez Canal University
- Investigators
- Zakia M Ibraheim, MD, Study chair, Professor of Gynecology and ObstetricsMariam L Mohammed, MD, Study director, Assistant Professor of Gynecology and ObstetricsHanan M Ghoneim, MD, Study director, Assistant Professor of Gynecology and ObstetricsAhmed M Abbas, MD, Study director, Assistant Professor of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492150
- Sponsor's protocol ID
- 4018
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04492150
- Acronym / sponsor ID
- 4018
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 10 Sep 2020 (estimated)
- Study completion
- 10 Oct 2020 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Dextrose 5%/Nacl 0.3% Inj_#3, Drug: Salinewomen who will receive 250 mL/hour of dextrose 5% with normal saline in a 1:1 ratio. |
| control group | Active comparator | Drug: Salinewomen who will receive 250 mL/hour of normal saline for the whole duration of induction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrose 5%/Nacl 0.3% Inj_#3250 mL/hour of dextrose 5% intravenous drip | Drug | study group |
| Saline250 mL/hour of normal saline intravenous drip | Drug | control group, study group |
Primary outcome
the duration of labor
Time frame: 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.
1 secondary outcome
Rate of cesarean sections
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zakia M Ibraheim, MD study chair
Professor of Gynecology and Obstetrics
Mariam L Mohammed, MD study director
Assistant Professor of Gynecology and Obstetrics
Hanan M Ghoneim, MD study director
Assistant Professor of Gynecology and Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose 5%/Nacl 0.3% Inj_#3 and Saline in people with Induction of Labor Affected Fetus / Newborn, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salwa H Tammam, M. B. B. Ch (00201012869258, Dr.salwa.hussein.tammam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the duration of labor (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.