Preterm Premature Rupture of MembranePPROMNCT04413019
Domiciliary Versus Hospital Management of PPROM
An observational study of Preterm Premature Rupture of Membrane, run by Ahmed Mohammed Selim at 1 site in Egypt.
Trial summary
This study is designed to compare efficacy \& safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preterm Premature Rupture of Membrane
- What is being tested?
- Clinical follow up
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 3,662 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2019to 20 Oct 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include 3662 women with a history of preterm prelabor rupture of the membranes
Who may be able to join
None listed.
Who cannot join
- Query PPROM: A history of PPROM with no pooling of amniotic fluid from the cervix on a sterile speculum examination
- Maternal comorbidities (Diabetes mellitus, hypertension, etc.)
- Patients with placenta previa
- Amniotic fluid pocket on ultrasound < 2x2 cm
- Logistic problems interfering with follow-up
- Inability to check temperature every six hours, with parameters for notifying their clinician (temperature ≥38°C)
- Non-Dependable transportation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Planned Domiciliary Versus Hospital Care for Women With Preterm Prelabor Rupture of the Membranes (PPROM)
This study is designed to compare efficacy \& safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.
Read the detailed description
Background: PPROM is encountered in 2.0% to 3.5% of pregnancies. Domiciliary care management is developing more and more in obstetrics, with psychological benefits for patients as well as other financial benefits. Reliable discharge criteria have been mentioned by few studies for patients with PPROM. Studies had shown that domiciliary care management in a context of PPROM did not modify perinatal morbidity and mortality, and allows a prolongation of the latency period. However, eligibility criteria for domiciliary care management were heterogeneous
Aim of The Work: The aim of this study is to compare efficacy \& safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.
Patients \& Methods: The current trial was conducted at Ain Shams University Maternity Hospital. A total of 3662 pregnant women were recruited from the outpatient clinic \& emergency room and included in the study. Then, they were randomized into two groups; group (D) was counseled for home care management, while group (H) was hospitalized. Take-home baby was assessed as a primary outcome and other maternal, fetal \& neonatal complications were recorded \& moreover latency period, mode of delivery \& preference of care were assessed
- Conditions
- Preterm Premature Rupture of Membrane
- Being tested
- Clinical follow up
- 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.
Clinical follow upOther
Patients recruited in this study commenced antibiotic treatment according to the recent guidelines :
- Erythromycin 250 mg 4 times daily for 10 days following the diagnosis of PPROM, or until the women is established labor (whichever sooner)
- Penicillin may be used in patients who can't tolerate erythromycin
- In cases of penicillin allergy: Cefazolin 1 g intravenously every 8 hours for 48 hours, followed by cephalexin 500 mg orally four times daily for five days. These drugs provide coverage for both GBS and Escherichia coli, the two major causes of neonatal infection.
| Study group | Role | What they receive |
|---|---|---|
| Group (D): Planned domiciliary care. | Patients within this group will be counseled for home care with self-monitoring for any symptoms suggestive of preterm labor, maternal or fetal distress. Receives: Other: Clinical follow up | |
| Group (H): Planned hospital care. | Patients within this group will be admitted at hospital for close monitoring of maternal \& fetal wellbeing \& finally the neonatal outcome Receives: Other: Clinical follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Take-home baby
this outcome is the best indicator of success of the management plan when the outcome is alive \& well baby
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start15 Apr 2019
- Primary completion1 Oct 2020
- Study completion20 Oct 2020
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 MembraneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,662 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ahmed Mohammed Selim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mohammed Selim, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413019
- Sponsor's protocol ID
- PPROM
- Acronym
- PPROM
- Status last verified
- Jan 2021
- First submitted
- 29 May 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all statistical methods, results of the study ,discussion \& recommendations
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planned Domiciliary Versus Hospital Care for Women With Preterm Prelabor Rupture of the Membranes (PPROM)
- ClinicalTrials.gov ID
- NCT04413019
- Acronym / sponsor ID
- PPROM / PPROM
- Conditions
- Preterm Premature Rupture of Membrane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,662 participants (actual)
- Lead sponsor
- Ahmed Mohammed SelimUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 2 Jun 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.
This study is designed to compare efficacy \& safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.
Detailed description
Background: PPROM is encountered in 2.0% to 3.5% of pregnancies. Domiciliary care management is developing more and more in obstetrics, with psychological benefits for patients as well as other financial benefits. Reliable discharge criteria have been mentioned by few studies for patients with PPROM. Studies had shown that domiciliary care management in a context of PPROM did not modify perinatal morbidity and mortality, and allows a prolongation of the latency period. However, eligibility criteria for domiciliary care management were heterogeneous
Aim of The Work: The aim of this study is to compare efficacy \& safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.
Patients \& Methods: The current trial was conducted at Ain Shams University Maternity Hospital. A total of 3662 pregnant women were recruited from the outpatient clinic \& emergency room and included in the study. Then, they were randomized into two groups; group (D) was counseled for home care management, while group (H) was hospitalized. Take-home baby was assessed as a primary outcome and other maternal, fetal \& neonatal complications were recorded \& moreover latency period, mode of delivery \& preference of care were assessed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (D): Planned domiciliary care. | – | Other: Clinical follow upPatients within this group will be counseled for home care with self-monitoring for any symptoms suggestive of preterm labor, maternal or fetal distress. |
| Group (H): Planned hospital care. | – | Other: Clinical follow upPatients within this group will be admitted at hospital for close monitoring of maternal \& fetal wellbeing \& finally the neonatal outcome |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include 3662 women with a history of preterm prelabor rupture of the membranes
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Query PPROM: A history of PPROM with no pooling of amniotic fluid from the cervix on a sterile speculum examination
- Maternal comorbidities (Diabetes mellitus, hypertension, etc.)
- Patients with placenta previa
- Amniotic fluid pocket on ultrasound < 2x2 cm
- Logistic problems interfering with follow-up
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 |
|---|---|---|
| Clinical follow upPatients recruited in this study commenced antibiotic treatment according to the recent guidelines : * Erythromycin 250 mg 4 times daily for 10 days following the diagnosis of PPROM, or until the women is established labor (whichever sooner) * Penicillin may be used in patients who can't tolerate erythromycin * In cases of penicillin allergy: Cefazolin 1 g intravenously every 8 hours for 48 hours, followed by cephalexin 500 mg orally four times daily for five days. These drugs provide coverage for both GBS and Escherichia coli, the two major causes of neonatal infection. | Other | Group (D): Planned domiciliary care., Group (H): Planned hospital care. |
Primary outcome
Take-home baby
Time frame: 2 years
this outcome is the best indicator of success of the management plan when the outcome is alive \& well baby
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: Yes. all statistical methods, results of the study ,discussion \& recommendations
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Premature Rupture of Membrane, run by Ahmed Mohammed Selim 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 0 inclusion and 7 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 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Take-home baby (time frame: 2 years). 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 6 Jan 2021.