Labor PainPhase 3NCT01635439
Prostin and Propess in Induction of Labor
A Phase 3 study testing Propess and Prostin E2 in people with Labor Pain, run by Ain Shams University at 1 site in Saudi Arabia.
Trial summary
The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Propess and Prostin E2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Dec 2010to Dec 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age 37 weeks or more
- Singleton pregnancy
- Cephalic presentation.
Who cannot join
- Previous cesarean section
- Any contraindication for vaginal delivery
- Suspected Cephalo-Pelvic Disproportion
- Unexplained antepartum Hemorrhage
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
NWAFH, North west Armed Forces Hospital
Tabuk, Tabuk Region, Box 100 Tabuk
About this study
Official title: Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.
The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).
Read the detailed description
A controlled release hydrophilic matrix (Controlled Therapeutics Ltd., East Kilbride, Scotland) which provides a gradual release of dinoprostone (prostaglandin E2) was introduced in 1995 (Propess, Ferring Pharmaceuticals). This preparation is used for the initiation or enhancement of cervical ripening in women at or after term with a singleton pregnancy and a cephalic presentation. Prostaglandin E2 causes softening and dilatation of the cervix and subsequently produces uterine contractions which may induce labour.
- Conditions
- Labor Pain
- Being tested
- Propess, Prostin E2
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropessDrug
Also called Intravaginal PGE2 insert
The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation.
Prostin E2Drug
Also called Dinoprostone (PGE2)vaginal tablets.
3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Propess | Active comparator | Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h. Receives: Drug: Propess |
| Prostin E2 | Active comparator | PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository. Receives: Drug: Prostin E2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction to Delivery Interval
Measured: 24 hours
Secondary outcomes (4)
Induction to Onset of Labor Interval
Measured: 24 hours
Uterine Hyper-stimulation Rate
Measured: 24 hours
Need for Syntocinon Augmentation
Measured: 24 hours
Normal Vaginal Delivery Rate
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 posted9 Jul 2012 (estimated)
- Study startDec 2010
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- North West Armed Forces Hospital
- Responsible party
- Principal investigator, Mohamed Ellaithy, Ain Shams University
- Investigators
- Ahmed Abdelaziz, M.D., Principal investigator, North West Armed Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635439
- Sponsor's protocol ID
- NWAFH2010-1
- Status last verified
- Jan 2014
- First submitted
- 4 Jul 2012
- Last updated
- 6 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Abdelaziz A, Mahmoud AA, Ellaithy MI, Abees SH. Pre-induction cervical ripening using two different dinoprostone vaginal preparations: A randomized clinical trial of tablets and slow release retrievable insert. Taiwan J Obstet Gynecol. 2018 Aug;57(4):560-566. doi: 10.1016/j.tjog.2018.06.016.
PubMed 30122579
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01635439
- Acronym / sponsor ID
- NWAFH2010-1
- Conditions
- Labor Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- North West Armed Forces Hospital
- Study start
- Dec 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Jul 2012 (estimated)
- Results
- Posted 4 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).
Detailed description
A controlled release hydrophilic matrix (Controlled Therapeutics Ltd., East Kilbride, Scotland) which provides a gradual release of dinoprostone (prostaglandin E2) was introduced in 1995 (Propess, Ferring Pharmaceuticals). This preparation is used for the initiation or enhancement of cervical ripening in women at or after term with a singleton pregnancy and a cephalic presentation. Prostaglandin E2 causes softening and dilatation of the cervix and subsequently produces uterine contractions which may induce labour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propess | Active comparator | Drug: PropessPropess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h. |
| Prostin E2 | Active comparator | Drug: Prostin E2PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Gestational age 37 weeks or more
- Singleton pregnancy
- Cephalic presentation.
Key exclusion criteria (4 listed)
- Previous cesarean section
- Any contraindication for vaginal delivery
- Suspected Cephalo-Pelvic Disproportion
- Unexplained antepartum Hemorrhage
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 |
|---|---|---|
| PropessAlso: Intravaginal PGE2 insertThe vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation. | Drug | Propess |
| Prostin E2Also: Dinoprostone (PGE2)vaginal tablets.3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation. | Drug | Prostin E2 |
Primary outcome
Induction to Delivery Interval
Time frame: 24 hours
4 secondary outcomes
Induction to Onset of Labor Interval
Time frame: 24 hours
Uterine Hyper-stimulation Rate
Time frame: 24 hours
Need for Syntocinon Augmentation
Time frame: 24 hours
Normal Vaginal Delivery Rate
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30122579Abdelaziz A, Mahmoud AA, Ellaithy MI, Abees SH. Pre-induction cervical ripening using two different dinoprostone vaginal preparations: A randomized clinical trial of tablets and slow release retrievable insert. Taiwan J Obstet Gynecol. 2018 Aug;57(4):560-566. doi: 10.1016/j.tjog.2018.06.016.
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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.
Ahmed Abdelaziz, M.D. principal investigator
North West Armed Forces Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propess and Prostin E2 in people with Labor Pain, run by Ain Shams University at 1 site in Saudi Arabia.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 6 Feb 2014. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction to Delivery Interval (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635439, which also lists 1 linked publication.
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 6 Feb 2014.