Examining changes in pregnant women with preterm premature rupture of membranes
Investigation of Biochemical Changes in Maternal Blood as Well as Histological Changes in the Placenta and Amniotic Membrane of Pregnant Women Diagnosed With Preterm Premature Rupture of Membrane
Celal Bayar University · NCT06639919
This study looks at changes in the placenta of healthy pregnant women who have experienced early water breaking to see how certain proteins might affect their pregnancy outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Celal Bayar University (other) |
| Locations | 1 site (Yunusemre, Mani̇sa) |
| Trial ID | NCT06639919 on ClinicalTrials.gov |
What this trial studies
This observational study investigates biochemical and histological changes in pregnant women who experience preterm premature rupture of membranes (PPROM). It aims to understand the role of proteoglycans, particularly syndecans, in the placenta and their interactions with various ligands that may influence pregnancy outcomes. The study will include healthy pregnant women under 37 weeks gestation, focusing on those without additional health complications. Data will be collected to identify potential risk factors and underlying mechanisms associated with PPROM.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy pregnant women aged 18-50, under 37 weeks of gestation, who are literate in Turkish.
Not a fit: Patients with high-risk pregnancies, multiple pregnancies, or those with certain health conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of PPROM, potentially leading to improved management and outcomes for affected pregnancies.
How similar studies have performed: While there is ongoing research into PPROM and placental health, this specific focus on syndecans and their biochemical roles in PPROM is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy pregnancy under 37 weeks * Age range 18-50 * Being literate in Turkish * Not having any additional disease * Agreeing to participate in the study Exclusion Criteria: * High-risk pregnancies (gestational hypertension, preeclampsia, HELLP syndrome, chronic hypertension, gestational and pregestational diabetes, cholestasis, intrauterine growth retardation, etc.) * Multiple pregnancy * Pregnant women under the age of 18 * Smoking * Medication use (excluding routinely used food supplements during pregnancy) * Additional disease (thyroid, renal failure, liver failure, hepatitis, heart disease, connective tissue disease, etc.) * Immunosuppressive use * Presence of active or chronic infection * Presence of active or chronic inflammatory disease * Patients who gave birth at an external center or later chose to withdraw from the study * Patients who did not have any exclusion criteria at the time of PPROM or when blood was drawn for the control group, but who later developed any exclusion criteria. * Premature birth of patients included in the control group
Where this trial is running
Yunusemre, Mani̇sa
- Manisa Celal Bayar University — Yunusemre, Mani̇sa, Turkey (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Premature Rupture of Membrane, Placenta Diseases, Preterm Premature Membrane Rupture, Premature membrane rupture, Syndecan, Placenta, Amniotic membrane, Proteoglycan