Premature Rupture of MembraneAFI in PPROMNCT04100252
The Impact of Amniotic Fluid Index (AFI) on Maternal and Perinatal Outcomes in Pregnant Women With Preterm Premature Rupture of Membranes
An observational study of Premature Rupture of Membrane and Amniotic Fluid Leakage, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Pregnant women who admitted with the complaint of amniotic fluid leakage between the gestational ages of 23+0 and 33+0 and who finally were diagnosed as PPROM were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premature Rupture of Membrane, Amniotic Fluid Leakage, Maternal Complication of Pregnancy
- What is being tested?
- AFI via transabdominal ultrasonography
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2018to 1 Sep 2019
- 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
- No healthy volunteers
- Adult
Study population: Pregnant women who were diagnosed as PPROM between 23+0 and 33+0 gestational ages.
Who may be able to join
- Pregnant women Diagnosis of PPROM between 23+0 and 33+0 gestational ages. -
Who cannot join
- Multiple gestations, C Cervical dilatation above 6 cm at the admission, Hypertensive diseases, Cervical cerclage, Fetal anomalies, Oligohydramnios, Polihydramnios, Those who declined to participate in the study.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University, Goztepe Research and Training Hospital
Istanbul, Kadikoy, 34722
About this study
Official title: The Impact of Amniotic Fluid Index (AFI) on Maternal and Perinatal Outcomes in Pregnant Women With Preterm Premature Rupture of Membranes (PPROM)
Pregnant women who admitted with the complaint of amniotic fluid leakage between the gestational ages of 23+0 and 33+0 and who finally were diagnosed as PPROM were included in the study. Women with multiple gestations, cervical dilatation above 6 cm at the admission, hypertensive diseases, cervical cerclage, fetal anomalies, olgohydramnios, polihydramnios, and those who declined to involve in the study were excluded.
In all included women were examined at the admission for amniotic fluid index via trans abdominal ultrasonography. AFI were measured by four quadrant technique, which is sum of the deepest vertical length of pocket of fluid in each quadrant without any umbilical cord. All included patients were assessed in two groups; women with AFI<5 and those with AFI≥5 cm.
Included patients were followed in terms of maternal and fetal complications. Maternal complications were chorioamnionitis, placental abruption, placental retention, postpartum endometritis, postpartum hemorrhage; while fetal complications comprised necessity of admission to neonatal intensive care unit, neonatal sepsis, meconium aspiration syndrome, respiratory distress syndrome, intraventricular hemorrhage, umbilical cord pH below 7.10, APGAR score of 5th minute below 5. All complication rates were compared between the groups. In addition, the time period between the diagnosis of PPROM and the time of delivery was defined as latency period and were compared between the groups.
Read the detailed description
Pregnant women who admitted with the complaint of amniotic fluid leakage between the gestational ages of 23+0 and 33+0 were examined for the inclusion criteria of the study. Among them, women with usual history of gross amniotic fluid leakage as well as classical speculum findings of ROM, such as pooling of amnitotic fluid within the posterior fornix or vaginal wall, were diagnosed as PPROM and included in the study without any further investigation. In case of the absence of these findings and suspected cases, PPROM was diagnosed via placental alpha-microglobulin-1 test from the vaginal fluid. Those with positive test results were included in the study. Women with multiple gestations, cervical dilatation above 6 cm at the admission, hypertensive diseases, cervical cerclage, fetal anomalies, olgohydramnios, polihydramnios, and those who declined to involve in the study were excluded.
In all included women were examined at the admission for amniotic fluid index via trans abdominal ultrasonography. AFI were measured by four quadrant technique, which is sum of the deepest vertical length of pocket of fluid in each quadrant without any umbilical cord. All included patients were assessed in two groups; women with AFI<5 and those with AFI≥5 cm.
Included patients were followed in terms of maternal and fetal complications. Maternal complications were chorioamnionitis, placental abruption, placental retention, postpartum endometritis, postpartum hemorrhage; while fetal complications comprised necessity of admission to neonatal intensive care unit, neonatal sepsis, meconium aspiration syndrome, respiratory distress syndrome, intraventricular hemorrhage, umbilical cord pH below 7.10, APGAR score of 5th minute below 5. All complication rates were compared between the groups. In addition, the time period between the diagnosis of PPROM and the time of delivery was defined as latency period and were compared between the groups.
- Conditions
- Premature Rupture of Membrane, Amniotic Fluid Leakage, Maternal Complication of Pregnancy, Fetal Complications
- Being tested
- AFI via transabdominal ultrasonography
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFI via transabdominal ultrasonographyOther
AFI via transabdominal ultrasonography was performed at the time of diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Women with AFI<5 cm at the time of PPROM diagnosis) | Pregnant women who were diagnosed PPROM the gestational ages of 23+0 and 33+0 were examined ultrasonographically at the first admission. Women with AFI<5 were enrolled in the Group 1. Receives: Other: AFI via transabdominal ultrasonography | |
| Group 2 (Women with AFI≥5 cm at the time of PPROM diagnosis) | Pregnant women who were diagnosed PPROM the gestational ages of 23+0 and 33+0 were examined ultrasonographically at the first admission. Women with AFI≥5 were enrolled in the Group 2. Receives: Other: AFI via transabdominal ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Pregnant Women experiencing Complications
Adverse events emerging in included pregnant women from the time of PPROM diagnosis to the end of the postpartum 1st month
Measured: Through study completion, an average of 1 year
Number of fetuses and newborns experiencing complications
Adverse events emerging in fetuses and neonates from the time of PPROM diagnosis to the end of the postpartum 1st month
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Latency Time
The time period from the PPROM diagnosis to delivery.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Sep 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özkan Özdamar, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100252
- Sponsor's protocol ID
- 2018/0480
- Acronym
- AFI in PPROM
- Status last verified
- Sep 2019
- First submitted
- 10 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be assessed
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Amniotic Fluid Index (AFI) on Maternal and Perinatal Outcomes in Pregnant Women With Preterm Premature Rupture of Membranes (PPROM)
- ClinicalTrials.gov ID
- NCT04100252
- Acronym / sponsor ID
- AFI in PPROM / 2018/0480
- Conditions
- Premature Rupture of Membrane, Amniotic Fluid Leakage, Maternal Complication of Pregnancy, Fetal Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 24 Sep 2019 (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.
Pregnant women who admitted with the complaint of amniotic fluid leakage between the gestational ages of 23+0 and 33+0 and who finally were diagnosed as PPROM were included in the study. Women with multiple gestations, cervical dilatation above 6 cm at the admission, hypertensive diseases, cervical cerclage, fetal anomalies, olgohydramnios, polihydramnios, and those who declined to involve in the study were excluded.
In all included women were examined at the admission for amniotic fluid index via trans abdominal ultrasonography. AFI were measured by four quadrant technique, which is sum of the deepest vertical length of pocket of fluid in each quadrant without any umbilical cord. All included patients were assessed in two groups; women with AFI<5 and those with AFI≥5 cm.
Included patients were followed in terms of maternal and fetal complications. Maternal complications were chorioamnionitis, placental abruption, placental retention, postpartum endometritis, postpartum hemorrhage; while fetal complications comprised necessity of admission to neonatal intensive care unit, neonatal sepsis, meconium aspiration syndrome, respiratory distress syndrome, intraventricular hemorrhage, umbilical cord pH below 7.10, APGAR score of 5th minute below 5. All complication rates were compared between the groups. In addition, the time period between the diagnosis of PPROM and the time of delivery was defined as latency period and were compared between the groups.
Detailed description
Pregnant women who admitted with the complaint of amniotic fluid leakage between the gestational ages of 23+0 and 33+0 were examined for the inclusion criteria of the study. Among them, women with usual history of gross amniotic fluid leakage as well as classical speculum findings of ROM, such as pooling of amnitotic fluid within the posterior fornix or vaginal wall, were diagnosed as PPROM and included in the study without any further investigation. In case of the absence of these findings and suspected cases, PPROM was diagnosed via placental alpha-microglobulin-1 test from the vaginal fluid. Those with positive test results were included in the study. Women with multiple gestations, cervical dilatation above 6 cm at the admission, hypertensive diseases, cervical cerclage, fetal anomalies, olgohydramnios, polihydramnios, and those who declined to involve in the study were excluded.
In all included women were examined at the admission for amniotic fluid index via trans abdominal ultrasonography. AFI were measured by four quadrant technique, which is sum of the deepest vertical length of pocket of fluid in each quadrant without any umbilical cord. All included patients were assessed in two groups; women with AFI<5 and those with AFI≥5 cm.
Included patients were followed in terms of maternal and fetal complications. Maternal complications were chorioamnionitis, placental abruption, placental retention, postpartum endometritis, postpartum hemorrhage; while fetal complications comprised necessity of admission to neonatal intensive care unit, neonatal sepsis, meconium aspiration syndrome, respiratory distress syndrome, intraventricular hemorrhage, umbilical cord pH below 7.10, APGAR score of 5th minute below 5. All complication rates were compared between the groups. In addition, the time period between the diagnosis of PPROM and the time of delivery was defined as latency period and were compared between the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Women with AFI<5 cm at the time of PPROM diagnosis) | – | Other: AFI via transabdominal ultrasonographyPregnant women who were diagnosed PPROM the gestational ages of 23+0 and 33+0 were examined ultrasonographically at the first admission. Women with AFI<5 were enrolled in the Group 1. |
| Group 2 (Women with AFI≥5 cm at the time of PPROM diagnosis) | – | Other: AFI via transabdominal ultrasonographyPregnant women who were diagnosed PPROM the gestational ages of 23+0 and 33+0 were examined ultrasonographically at the first admission. Women with AFI≥5 were enrolled in the Group 2. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women who were diagnosed as PPROM between 23+0 and 33+0 gestational ages.
Key inclusion criteria (1 listed)
- Pregnant women Diagnosis of PPROM between 23+0 and 33+0 gestational ages. -
Key exclusion criteria (2 listed)
- Multiple gestations, C Cervical dilatation above 6 cm at the admission, Hypertensive diseases, Cervical cerclage, Fetal anomalies, Oligohydramnios, Polihydramnios, Those who declined to participate in the study.
- -
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 |
|---|---|---|
| AFI via transabdominal ultrasonographyAFI via transabdominal ultrasonography was performed at the time of diagnosis. | Other | Group 1 (Women with AFI<5 cm at the time of PPROM diagnosis), Group 2 (Women with AFI≥5 cm at the time of PPROM diagnosis) |
Primary outcome
Number of Pregnant Women experiencing Complications
Time frame: Through study completion, an average of 1 year
Adverse events emerging in included pregnant women from the time of PPROM diagnosis to the end of the postpartum 1st month
Number of fetuses and newborns experiencing complications
Time frame: Through study completion, an average of 1 year
Adverse events emerging in fetuses and neonates from the time of PPROM diagnosis to the end of the postpartum 1st month
1 secondary outcome
Latency Time
Time frame: Through study completion, an average of 1 year
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 24 Sep 2019.
- Individual participant dataSharing planned: Yes. To be assessed
Related trials for Premature Rupture of Membrane
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Active, not recruitingPhase 3
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Premature Rupture of Membrane
Not yet recruitingObservational study
Preterm Parturation Study
Preterm Parturation, Preterm Premature Rupture of Membranes (PPROM)
Not yet recruitingObservational study
Prediction of Latency Interval in Patients With Preterm Prelabor Rupture of Membranes
Preterm Prelabor Rupture of Membranes (PPROM)
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 Premature Rupture of Membrane and Amniotic Fluid Leakage, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 24 Sep 2019. 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 Turkey (Türkiye). 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?
Number of Pregnant Women experiencing Complications (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 24 Sep 2019.