Management of Preterm Prelabor Rupture of MembranesNCT05755841
Outpatient Management of Preterm Prelabor Rupture of Membranes
An observational study of Management of Preterm Prelabor Rupture of Membranes, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Home-care management is possible if patients are clinically stable forty-eight hours after Preterm Prelabour Rupture of the membrane with no clinical or biological signs suggestive of intrauterine infection. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Management of Preterm Prelabor Rupture of Membranes
- What is being tested?
- Outpatient management of preterm prelabor rupture of membranes and Inpatient management of preterm prelabor rupture of membranes
- How many people
- 71 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Mar 2023
- 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 18 to 40 years
- Women only
- Adult
Study population: Pregnant women admitted to Ain Shams University Maternity Hospital due to preterm prelabor rupture of membranes
Who may be able to join
- Gestational age 28-34 weeks as calculated from the Last Menstrual period, Ultrasound examination in early 2nd trimester at 14 weeks, or first trimetric ultrasound.
- Confirmed preterm Prelabour rupture of membranes using a Sterile Cusco speculum examination, definitive history of gush of watery discharge or ultrasound measurement of the deepest vertical pocket <2cm.
Who cannot join
- Mutiple pregnancy
- Cases with congenital fetal malformations conditioning prognosis
- Preterm prelabor rupture of membranes associated with preeclampsia, Diabetes mellitus, Systemic lupus erythematosus, long term steroid therapy, Renal/hepatic impairment
- Preterm Prelabour Rupture of membrane-associated with antepartum hemorrhage or asymptomatic Placenta Previa
- Past history of classic Cesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inpatient Versus Outpatient Management of Preterm Prelabour Rupture of Membrane. A Prospective Cohort Study
Home-care management is possible if patients are clinically stable forty-eight hours after Preterm Prelabour Rupture of the membrane with no clinical or biological signs suggestive of intrauterine infection. Several retrospective studies have highlighted the safety of such outpatient management for women with nonthreatening Preterm Prelabour Rupture of the membrane. This prospective cohort study will compare inpatient versus outpatient management of preterm Prelabour rupture of membrane regarding latency, intra-amniotic infection, birth weight, and neonatal complications at 28 to 34 weeks of gestation after 48 hours of admission to Ain-Shams University Maternity Hospital.
Read the detailed description
The fetal membranes are made of two histological layers, the amnion in contact with the amniotic fluid, and the chorion in contact with the maternal decidua. They engrave the fetus during pregnancy and serve as a barrier between the maternal and fetal compartments, supplying both physicochemical and biochemical defense against external shocks and rising vaginal flora bacteria.
Membrane rupture is a biochemical phenomenon that happens towards the conclusion of birth. The programmed weakening of the Para cervical region, marked by collagen remodeling and apoptosis coupled with uterine contractions that produce stretching and shearing forces, contributes to the breakup of the membranes.
The rupture that happens before initiating contractions in 10% of pregnancies is called "Prelabour membrane rupture" (PROM). About 3% of women undergo Prelabour Rupture of the membrane before 37 weeks of birth, which is considered preterm pre-labor membrane breakup (PPROM). This condition is responsible for one-third of preterm births and raises perinatal morbidity and mortality primarily due to the risk of intrauterine infection, which may lead to early neonatal infection, necrotizing enterocolitis, and uterine fetal death
In spite of major progress in antenatal management over the past three decades, Prelabour membrane rupture and prenatal birth are still common. About 50 percent of women with Preterm Prelabour Rupture of the membrane (<37 WG) bear children within 24-48 hours after rupture and 70 percent to 90 percent within 7 days. Patients with Preterm Prelabour Rupture of the membrane need clinical treatment in a hospital that has the required services for premature babies. When the point of fetal viability is met, Preterm Prelabour Rupture of the membrane is initially hospital-based and consists of antibiotic prophylaxis and corticosteroids for fetal lung maturation. The key surveillance priorities are the diagnosis and treatment of maternal and fetal complications, in particular intrauterine infections. Home-care treatment is possible if patients are clinically stable 48 hours post Prelabour Rupture of the membrane with no clinical or biological symptoms of intrauterine infection. The protection of such outpatient management for women with non-threatening Preterm Prelabour Rupture of the membrane has been illustrated in many retrospective studies.
Home-care inclusion requirements are based on gestational age, lack of chorioamnionitis, physiological reliability at least 72 hours after Preterm Prelabour Rupture of the membrane (up to 7 days depending on the study), cervical dilation, and patient at home. The time between membrane breakup and labor initiation, referred to as latency, is stated to be correlated with neonatal morbidity and mortality. While certain factors, such as gestational age at Preterm Prelabour Rupture of the membrane, cervical dilation, parity, twin pregnancy, and chorioamnionitis, have been reported to affect latency in the literature, the time between rupture and delivery remains difficult to predict. Awareness of short-term predictive variables could optimize the length of hospital stay and help forecast the likelihood of adverse perinatal outcomes.
- Being tested
- Outpatient management of preterm prelabor rupture of membranes, Inpatient management of preterm prelabor rupture of membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient management of preterm prelabor rupture of membranesOther
Patients who will be managed as outpatients will be discharged after 48 hours of hospitalization with the following management:
- Twice weekly fetal cardiotocography.
- Complete blood count once a week.
- A weekly clinical and ultrasound examination.
Inpatient management of preterm prelabor rupture of membranesOther
In the Inpatient Care Policy group, the same protocol as outpatient group will be applied, but the patient will not be discharged until delivery.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Outpatient management of preterm prelabor rupture of membranes Receives: Other: Outpatient management of preterm prelabor rupture of membranes | |
| 2 | Inpatient management of preterm prelabor rupture of membranes Receives: Other: Inpatient management of preterm prelabor rupture of membranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency period
the interval between rupture of the membranes and the onset of labor.
Measured: From the time of membrane rupture till the time of delivery
Secondary outcomes (2)
Intraamniotic infection
▪ Intra-amniotic infection, will be diagnosed clinically :
- Maternal fever >38°c.
- Purulent cervical discharge.
- Fetal tachycardia>160 beats/min.
Measured: From the time of membrane rupture till the time of delivery
Birth weight
Neonatal birth weight
Measured: First 24 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 posted6 Mar 2023
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Management of Preterm Prelabor 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755841
- Sponsor's protocol ID
- 9
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Richardson L, Kim S, Menon R, Han A. Organ-On-Chip Technology: The Future of Feto-Maternal Interface Research? Front Physiol. 2020 Jun 30;11:715. doi: 10.3389/fphys.2020.00715. eCollection 2020.
PubMed 32695021Kumar D, Moore RM, Mercer BM, Mansour JM, Redline RW, Moore JJ. The physiology of fetal membrane weakening and rupture: Insights gained from the determination of physical properties revisited. Placenta. 2016 Jun;42:59-73. doi: 10.1016/j.placenta.2016.03.015. Epub 2016 Apr 1.
PubMed 27238715Mercer, B.M. (2012), I240 MANAGEMENT OF PTL/PPROM. International Journal of Gynecology & Obstetrics, 119: S221-S221
Souza RT, Cecatti JG. A Comprehensive Integrative Review of the Factors Associated with Spontaneous Preterm Birth, Its Prevention and Prediction, Including Metabolomic Markers. Rev Bras Ginecol Obstet. 2020 Jan;42(1):51-60. doi: 10.1055/s-0040-1701462. Epub 2020 Feb 27.
PubMed 32107766Hume, Robert. (2014). The Value of Money in Eighteenth-Century England: Incomes, Prices, Buying Power-and Some Problems in Cultural Economics. Huntington Library Quarterly. 77. 373-416.
Schmitz T, Sentilhes L, Lorthe E, Gallot D, Madar H, Doret-Dion M, Beucher G, Charlier C, Cazanave C, Delorme P, Garabedian C, Azria E, Tessier V, Senat MV, Kayem G. Preterm premature rupture of the membranes: Guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2019 May;236:1-6. doi: 10.1016/j.ejogrb.2019.02.021. Epub 2019 Mar 2.
PubMed 30870741Guckert M, Clouqueur E, Drumez E, Petit C, Houfflin-Debarge V, Subtil D, Garabedian C. Is homecare management associated with longer latency in preterm premature rupture of membranes? Arch Gynecol Obstet. 2020 Jan;301(1):61-67. doi: 10.1007/s00404-019-05363-x. Epub 2019 Nov 23.
PubMed 31760462Ministry of Health. 2021. Induction of Labour in Aotearoa New Zealand: A clinical practice guideline 2019. Wellington: Ministry of Health
Kibel M, Asztalos E, Barrett J, Dunn MS, Tward C, Pittini A, Melamed N. Outcomes of Pregnancies Complicated by Preterm Premature Rupture of Membranes Between 20 and 24 Weeks of Gestation. Obstet Gynecol. 2016 Aug;128(2):313-320. doi: 10.1097/AOG.0000000000001530.
PubMed 27400016Bouchghoul H, Kayem G, Schmitz T, Benachi A, Sentilhes L, Dussaux C, Senat MV. Outpatient versus inpatient care for preterm premature rupture of membranes before 34 weeks of gestation. Sci Rep. 2019 Mar 12;9(1):4280. doi: 10.1038/s41598-019-40585-8.
PubMed 30862787Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
PubMed 32080050
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Versus Outpatient Management of Preterm Prelabour Rupture of Membrane. A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05755841
- Acronym / sponsor ID
- 9
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 6 Mar 2023 (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.
Home-care management is possible if patients are clinically stable forty-eight hours after Preterm Prelabour Rupture of the membrane with no clinical or biological signs suggestive of intrauterine infection. Several retrospective studies have highlighted the safety of such outpatient management for women with nonthreatening Preterm Prelabour Rupture of the membrane. This prospective cohort study will compare inpatient versus outpatient management of preterm Prelabour rupture of membrane regarding latency, intra-amniotic infection, birth weight, and neonatal complications at 28 to 34 weeks of gestation after 48 hours of admission to Ain-Shams University Maternity Hospital.
Detailed description
The fetal membranes are made of two histological layers, the amnion in contact with the amniotic fluid, and the chorion in contact with the maternal decidua. They engrave the fetus during pregnancy and serve as a barrier between the maternal and fetal compartments, supplying both physicochemical and biochemical defense against external shocks and rising vaginal flora bacteria.
Membrane rupture is a biochemical phenomenon that happens towards the conclusion of birth. The programmed weakening of the Para cervical region, marked by collagen remodeling and apoptosis coupled with uterine contractions that produce stretching and shearing forces, contributes to the breakup of the membranes.
The rupture that happens before initiating contractions in 10% of pregnancies is called "Prelabour membrane rupture" (PROM). About 3% of women undergo Prelabour Rupture of the membrane before 37 weeks of birth, which is considered preterm pre-labor membrane breakup (PPROM). This condition is responsible for one-third of preterm births and raises perinatal morbidity and mortality primarily due to the risk of intrauterine infection, which may lead to early neonatal infection, necrotizing enterocolitis, and uterine fetal death
In spite of major progress in antenatal management over the past three decades, Prelabour membrane rupture and prenatal birth are still common. About 50 percent of women with Preterm Prelabour Rupture of the membrane (<37 WG) bear children within 24-48 hours after rupture and 70 percent to 90 percent within 7 days. Patients with Preterm Prelabour Rupture of the membrane need clinical treatment in a hospital that has the required services for premature babies. When the point of fetal viability is met, Preterm Prelabour Rupture of the membrane is initially hospital-based and consists of antibiotic prophylaxis and corticosteroids for fetal lung maturation. The key surveillance priorities are the diagnosis and treatment of maternal and fetal complications, in particular intrauterine infections. Home-care treatment is possible if patients are clinically stable 48 hours post Prelabour Rupture of the membrane with no clinical or biological symptoms of intrauterine infection. The protection of such outpatient management for women with non-threatening Preterm Prelabour Rupture of the membrane has been illustrated in many retrospective studies.
Home-care inclusion requirements are based on gestational age, lack of chorioamnionitis, physiological reliability at least 72 hours after Preterm Prelabour Rupture of the membrane (up to 7 days depending on the study), cervical dilation, and patient at home. The time between membrane breakup and labor initiation, referred to as latency, is stated to be correlated with neonatal morbidity and mortality. While certain factors, such as gestational age at Preterm Prelabour Rupture of the membrane, cervical dilation, parity, twin pregnancy, and chorioamnionitis, have been reported to affect latency in the literature, the time between rupture and delivery remains difficult to predict. Awareness of short-term predictive variables could optimize the length of hospital stay and help forecast the likelihood of adverse perinatal outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Outpatient management of preterm prelabor rupture of membranesOutpatient management of preterm prelabor rupture of membranes |
| 2 | – | Other: Inpatient management of preterm prelabor rupture of membranesInpatient management of preterm prelabor rupture of membranes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women admitted to Ain Shams University Maternity Hospital due to preterm prelabor rupture of membranes
Key inclusion criteria (2 listed)
- Gestational age 28-34 weeks as calculated from the Last Menstrual period, Ultrasound examination in early 2nd trimester at 14 weeks, or first trimetric ultrasound.
- Confirmed preterm Prelabour rupture of membranes using a Sterile Cusco speculum examination, definitive history of gush of watery discharge or ultrasound measurement of the deepest vertical pocket <2cm.
Key exclusion criteria (5 listed)
- Mutiple pregnancy
- Cases with congenital fetal malformations conditioning prognosis
- Preterm prelabor rupture of membranes associated with preeclampsia, Diabetes mellitus, Systemic lupus erythematosus, long term steroid therapy, Renal/hepatic impairment
- Preterm Prelabour Rupture of membrane-associated with antepartum hemorrhage or asymptomatic Placenta Previa
- Past history of classic Cesarean section
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 management of preterm prelabor rupture of membranesPatients who will be managed as outpatients will be discharged after 48 hours of hospitalization with the following management: * Twice weekly fetal cardiotocography. * Complete blood count once a week. * A weekly clinical and ultrasound examination. | Other | 1 |
| Inpatient management of preterm prelabor rupture of membranesIn the Inpatient Care Policy group, the same protocol as outpatient group will be applied, but the patient will not be discharged until delivery. | Other | 2 |
Primary outcome
Latency period
Time frame: From the time of membrane rupture till the time of delivery
the interval between rupture of the membranes and the onset of labor.
2 secondary outcomes
Intraamniotic infection
Time frame: From the time of membrane rupture till the time of delivery
Birth weight
Time frame: First 24 hours after delivery
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 22 Mar 2023.
- Background: PubMed 32695021Richardson L, Kim S, Menon R, Han A. Organ-On-Chip Technology: The Future of Feto-Maternal Interface Research? Front Physiol. 2020 Jun 30;11:715. doi: 10.3389/fphys.2020.00715. eCollection 2020.
- Background: PubMed 27238715Kumar D, Moore RM, Mercer BM, Mansour JM, Redline RW, Moore JJ. The physiology of fetal membrane weakening and rupture: Insights gained from the determination of physical properties revisited. Placenta. 2016 Jun;42:59-73. doi: 10.1016/j.placenta.2016.03.015. Epub 2016 Apr 1.
- BackgroundMercer, B.M. (2012), I240 MANAGEMENT OF PTL/PPROM. International Journal of Gynecology & Obstetrics, 119: S221-S221
- Background: PubMed 32107766Souza RT, Cecatti JG. A Comprehensive Integrative Review of the Factors Associated with Spontaneous Preterm Birth, Its Prevention and Prediction, Including Metabolomic Markers. Rev Bras Ginecol Obstet. 2020 Jan;42(1):51-60. doi: 10.1055/s-0040-1701462. Epub 2020 Feb 27.
- BackgroundHume, Robert. (2014). The Value of Money in Eighteenth-Century England: Incomes, Prices, Buying Power-and Some Problems in Cultural Economics. Huntington Library Quarterly. 77. 373-416.
- Background: PubMed 30870741Schmitz T, Sentilhes L, Lorthe E, Gallot D, Madar H, Doret-Dion M, Beucher G, Charlier C, Cazanave C, Delorme P, Garabedian C, Azria E, Tessier V, Senat MV, Kayem G. Preterm premature rupture of the membranes: Guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2019 May;236:1-6. doi: 10.1016/j.ejogrb.2019.02.021. Epub 2019 Mar 2.
- Background: PubMed 31760462Guckert M, Clouqueur E, Drumez E, Petit C, Houfflin-Debarge V, Subtil D, Garabedian C. Is homecare management associated with longer latency in preterm premature rupture of membranes? Arch Gynecol Obstet. 2020 Jan;301(1):61-67. doi: 10.1007/s00404-019-05363-x. Epub 2019 Nov 23.
- BackgroundMinistry of Health. 2021. Induction of Labour in Aotearoa New Zealand: A clinical practice guideline 2019. Wellington: Ministry of Health
- Background: PubMed 27400016Kibel M, Asztalos E, Barrett J, Dunn MS, Tward C, Pittini A, Melamed N. Outcomes of Pregnancies Complicated by Preterm Premature Rupture of Membranes Between 20 and 24 Weeks of Gestation. Obstet Gynecol. 2016 Aug;128(2):313-320. doi: 10.1097/AOG.0000000000001530.
- Background: PubMed 30862787Bouchghoul H, Kayem G, Schmitz T, Benachi A, Sentilhes L, Dussaux C, Senat MV. Outpatient versus inpatient care for preterm premature rupture of membranes before 34 weeks of gestation. Sci Rep. 2019 Mar 12;9(1):4280. doi: 10.1038/s41598-019-40585-8.
- Background: PubMed 32080050Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
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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 Management of Preterm Prelabor 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 2 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: finished, as of the sponsor's last update on 22 Mar 2023. 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?
Latency period (time frame: From the time of membrane rupture till the time of delivery). 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 NCT05755841, which also lists 11 linked publications.
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 22 Mar 2023.