Preterm Premature Rupture of MembranesNCT02548013
Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management
A study testing outpatient management and Inpatient management in people with Preterm Premature Rupture of Membranes, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
This study is to compare the maternal and neonatal outcomes in the patients with PPROM who are managed at home versus those managed at hospital, half the patients will be managed at home and the other half will be managed inpatient. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Premature Rupture of Membranes
- What is being tested?
- outpatient management and Inpatient management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2014to Jul 2016
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PPROM with gestational age between 27 to 34 weeks
- Cephalic presentation
- Clear amniotic fluid
- Oral temperature > 38 C
- Near distance from the hospital (the patient can reach hospital within one hour )
- Home environment safe and amenable to rest , availability of family support such as a sister or mother who will help the patient at home .
- Maternal and fetal condition remain stable after hospitalization for 72 hours
Who cannot join
- Patient with equivocal diagnosis of rupture of membranes
- advanced labor
- intrauterine infection
- vaginal bleeding or
- non reassuring fetal heart rate.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity hospital
Cairo, Abbasya, 11821
Ahmad m Mamdouh, 00201227456554, ahmadreyad@hotmail.com
About this study
Official title: Is Outpatient Management of PPROM Equivalent to Hospital Management
This study is to compare the maternal and neonatal outcomes in the patients with PPROM who are managed at home versus those managed at hospital, half the patients will be managed at home and the other half will be managed inpatient.
Read the detailed description
Now the current practice is to manage patients with PPROM at hospital, however it is not known yet whether this practice is better than outpatient management as regard maternal and neonatal outcome.
There is some recent evidence that home management of PPROM is safe for both mother and neonate, home management is also more convenient with less expenses.
- Conditions
- Preterm Premature Rupture of Membranes
- Being tested
- outpatient management, Inpatient management
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient managementOther
patients if stable will be discharged to continue treatment at home
Inpatient managementOther
patients will continue there treatment in hospital till delivery
| Study group | Role | What they receive |
|---|---|---|
| Home management | Experimental | outpatient management patients if stable will be discharged to continue treatment at home Receives: Other: outpatient management |
| hospital management | Active comparator | Inpatient management patients will continue there treatment in hospital till delivery Receives: Other: Inpatient management |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate occurence of Neonatal sepsis
proven neonatal infection with positive blood culture within 48 hours after birth, or culture proven neonatal pneumonia or meningitis
Measured: 48 hours after delivery
Secondary outcomes (1)
rate of occurence of Maternal morbidity
including chorioamnionitis , endometritis , septicaemia, admission to intensive care unit, organ failure, major postpartum hemorrhage
Measured: 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of MembranesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, dina mostafa ibrahim, Ain Shams Maternity Hospital
- Investigators
- Maged R Aboseda, professor, Study chair, Ain Shams University maternity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548013
- Sponsor's protocol ID
- Ain Shams MS PPROM
- Status last verified
- Sep 2015
- First submitted
- 25 Aug 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Outpatient Management of PPROM Equivalent to Hospital Management
- ClinicalTrials.gov ID
- NCT02548013
- Acronym / sponsor ID
- Ain Shams MS PPROM
- Conditions
- Preterm Premature Rupture of Membranes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 14 Sep 2015 (estimated)
- 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.
This study is to compare the maternal and neonatal outcomes in the patients with PPROM who are managed at home versus those managed at hospital, half the patients will be managed at home and the other half will be managed inpatient.
Detailed description
Now the current practice is to manage patients with PPROM at hospital, however it is not known yet whether this practice is better than outpatient management as regard maternal and neonatal outcome.
There is some recent evidence that home management of PPROM is safe for both mother and neonate, home management is also more convenient with less expenses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home management | Experimental | Other: outpatient managementoutpatient management patients if stable will be discharged to continue treatment at home |
| hospital management | Active comparator | Other: Inpatient managementInpatient management patients will continue there treatment in hospital till delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- PPROM with gestational age between 27 to 34 weeks
- Cephalic presentation
- Clear amniotic fluid
- Oral temperature > 38 C
- Near distance from the hospital (the patient can reach hospital within one hour )
Key exclusion criteria (5 listed)
- Patient with equivocal diagnosis of rupture of membranes
- advanced labor
- intrauterine infection
- vaginal bleeding or
- non reassuring fetal heart rate.
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 |
|---|---|---|
| outpatient managementpatients if stable will be discharged to continue treatment at home | Other | Home management |
| Inpatient managementpatients will continue there treatment in hospital till delivery | Other | hospital management |
Primary outcome
rate occurence of Neonatal sepsis
Time frame: 48 hours after delivery
proven neonatal infection with positive blood culture within 48 hours after birth, or culture proven neonatal pneumonia or meningitis
1 secondary outcome
rate of occurence of Maternal morbidity
Time frame: 48 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
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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.
Maged R Aboseda, professor study chair
Ain Shams University maternity hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing outpatient management and Inpatient management in people with Preterm Premature Rupture of Membranes, run by Ain Shams Maternity 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 7 inclusion and 5 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 14 Sep 2015. 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 Dina M Ibrahim (00201223603223, Dr_dinamostafa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate occurence of Neonatal sepsis (time frame: 48 hours after delivery). 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 14 Sep 2015.