Labor PainNCT03829592
TheEffect of pH on Misoprostol in Induction of Labor
A study testing misoprostol in a neutral media, misoprostol in an acidic media and misoprostol in an alkaline media in people with Labor Pain, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour . Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- misoprostol in a neutral media, misoprostol in an acidic media and misoprostol in an alkaline media
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Feb 2019to 12 Jul 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 20 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation
Who cannot join
- 1. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Algazeerah and Kasralainy hospital
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: TheEffect of pH on Misoprostol in Induction of Labor in Full Term Pregnancies
Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour .
Read the detailed description
Although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. Water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium
- Conditions
- Labor Pain
- Being tested
- misoprostol in a neutral media, misoprostol in an acidic media, misoprostol in an alkaline media
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostol in a neutral mediaDrug
Also called Drug (misoprostol + neutral media )
giving misoprostol in a neutral media
misoprostol in an acidic mediaDrug
Also called Drug ( Misoprostol + acidic media )
giving misoprostol in an acidic media
misoprostol in an alkaline mediaDrug
Also called Drug ( misoprostol + alkaline media )
giving misoprostol in an alkaline media
| Study group | Role | What they receive |
|---|---|---|
| misoprostol in neutral media | Placebo comparator | Intervention : misoprostol in a neutral media will be given to women to induce labour Receives: Drug: misoprostol in a neutral media |
| Misoprostol in acidic media | Active comparator | Intervention : misoprostol in acidic media will be given to induce labour Receives: Drug: misoprostol in an acidic media |
| Misoprostol in alkaline media | Sham comparator | Intervention : misoprostol in alkaline media will be given to induce labour Receives: Drug: misoprostol in an alkaline media |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will start lactive phase of labour after treatment
the number of women in a group who will enter in active labour faster than other groups
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start6 Feb 2019
- Primary completion10 May 2020
- Study completion12 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 paralle groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829592
- Sponsor's protocol ID
- Misoprostol
- Status last verified
- May 2020
- First submitted
- 1 Feb 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TheEffect of pH on Misoprostol in Induction of Labor in Full Term Pregnancies
- ClinicalTrials.gov ID
- NCT03829592
- Acronym / sponsor ID
- Misoprostol
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 12 Jul 2020 (estimated)
- First posted
- 4 Feb 2019 (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.
Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour .
Detailed description
Although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. Water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 paralle groups
| Arm | Type | Receives |
|---|---|---|
| misoprostol in neutral media | Placebo comparator | Drug: misoprostol in a neutral mediaIntervention : misoprostol in a neutral media will be given to women to induce labour |
| Misoprostol in acidic media | Active comparator | Drug: misoprostol in an acidic mediaIntervention : misoprostol in acidic media will be given to induce labour |
| Misoprostol in alkaline media | Sham comparator | Drug: misoprostol in an alkaline mediaIntervention : misoprostol in alkaline media will be given to induce labour |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation
Key exclusion criteria (1 listed)
- 1. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.
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 |
|---|---|---|
| misoprostol in a neutral mediaAlso: Drug (misoprostol + neutral media )giving misoprostol in a neutral media | Drug | misoprostol in neutral media |
| misoprostol in an acidic mediaAlso: Drug ( Misoprostol + acidic media )giving misoprostol in an acidic media | Drug | Misoprostol in acidic media |
| misoprostol in an alkaline mediaAlso: Drug ( misoprostol + alkaline media )giving misoprostol in an alkaline media | Drug | Misoprostol in alkaline media |
Primary outcome
The number of women who will start lactive phase of labour after treatment
Time frame: within 24 hours
the number of women in a group who will enter in active labour faster than other groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
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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.
Mahmoud Alalfy principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing misoprostol in a neutral media, misoprostol in an acidic media and misoprostol in an alkaline media in people with Labor Pain, run by Aljazeera Hospital 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 1 inclusion and 1 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 19 May 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of women who will start lactive phase of labour after treatment (time frame: within 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 19 May 2020.