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Status unknownNCT03829592Updated May 19, 2020

TheEffect of pH on Misoprostol in Induction of Labor

An interventional study of misoprostol in a neutral media and misoprostol in an acidic media in Labor Pain, sponsored by Aljazeera Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-19.

Sponsored by Aljazeera Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
20 Years to 42 Years
Sex
Female
01

Study 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 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

02

Conditions studied

  • Labor Pain

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03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's planned enrollment of 180 is above the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Aljazeera Hospital is the lead sponsor of 63 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation

Exclusion criteria

Exclusion Criteria:

    1. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Placebo comparator
    misoprostol in neutral media

    Intervention : misoprostol in a neutral media will be given to women to induce labour

    Drug: misoprostol in a neutral media

  • Active comparator
    Misoprostol in acidic media

    Intervention : misoprostol in acidic media will be given to induce labour

    Drug: misoprostol in an acidic media

  • Sham comparator
    Misoprostol in alkaline media

    Intervention : misoprostol in alkaline media will be given to induce labour

    Drug: misoprostol in an alkaline media

Interventions

  • Drugmisoprostol in a neutral media

    giving misoprostol in a neutral media

    Also known as: Drug (misoprostol + neutral media )

  • Drugmisoprostol in an acidic media

    giving misoprostol in an acidic media

    Also known as: Drug ( Misoprostol + acidic media )

  • Drugmisoprostol in an alkaline media

    giving misoprostol in an alkaline media

    Also known as: Drug ( misoprostol + alkaline media )

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: within 24 hours

07

Study locations

1 of 1 sites recruiting
  • Algazeerah and Kasralainy hospital
    Giza, Egypt
    • Mahmoud Alalfy, master · Contact · mahmoudalalfy@ymail.com · +201002611058
    • Ahmed Elgazzar, M.D · Contact · +201014005959
    • Mahmoud Alalfy, master · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03829592
Lead sponsor
Aljazeera Hospital
Collaborators
Kasr El Aini Hospital
Responsible party
Sponsor
First posted
Feb 4, 2019
Start date
Feb 6, 2019
Primary completion
May 10, 2020
Completion
Jul 12, 2020 (estimated)
Last update
May 19, 2020

Study contacts

Mahmoud Alalfy
principal investigator · Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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