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NCT04532021: MMP-14&PPROM
Matrix Metalloproteinase 14, Neopterin, and Orosomucoid 1 Levels in PPROM
trial testing matrix metalloproteinase 14, neopterin, and orosomucoid 1 measurements in Preterm Premature Rupture of Membranes in 88 participants. Status unknown.
30 August 2021
Quick facts
| Lead sponsor | Cengiz Gokcek Women's and Children's Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 88 |
| Start date | 25 August 2020 |
| Primary completion | 30 August 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- matrix metalloproteinase 14, neopterin, and orosomucoid 1 measurements
Conditions studied
- Preterm Premature Rupture of Membranes — all drugs for Preterm Premature Rupture of Membranes →
Sponsor
Cengiz Gokcek Women's and Children's Hospital
Who can join
Adults 18 to 40, female only, with Preterm Premature Rupture of Membranes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Introduction: To evaluate the maternal blood serum matrix metalloproteinase 14, neopterin, and orosomucoid 1 levels in pregnant women complicated by preterm premature rupture of membranes (PPROM) and to compare the results with healthy pregnancies. In addition, to determine whether maternal/umbilical cord blood concentrations of matrix metalloproteinase 14, neopterin, and orosomucoid 1 are of value in the diagnosis of histological chorioamnionitis in patients with preterm premature rupture of membranes (PPROM). Methods: This cohort study will be included 44 pregnant women with PPROM and 44 gestational age-matched healthy subjects in 24-32 weeks of pregnancy. The blood for analysis will be firstly obtained in maternal blood on the day of diagnosis at the study group. Healthy subjects who have a normal pregnancy and outcomes without any fetal-neonatal complications will be accepted into the control group. Forty-four gestational age-matched healthy pregnant women who will be delivered at term will be included in the study as the control group. In the control group, the pregnant women will be taken the maternal blood at the admission day. The women in both groups will be observed until the delivery and perinatal data will be noted. Then, the blood for analysis will be secondly obtained in maternal blood during termination of the pregnancy (or spontaneous labor) at the study group. Lastly, the blood for analysis will be also obtained in umbilical cord blood at the study group. These three markers levels will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. The placenta will be sent to histological examination in the study group. These three markers levels in women with PPROM will be compared to those of volunteer healthy pregnant women. In the study group, these three markers levels at maternal serum and cord serum will be evaluated for histological chorioamnionitis and maternal/neonatal outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04532021
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other Cengiz Gokcek Women's and Children's Hospital trials
Trials by the same sponsor.
- NCT04800705 — Levels of Selected Macroelements in Premature Ovarian Insufficiency · unknown
- NCT04767451 — Levels of Selected Microelements in Premature Ovarian Insufficiency · unknown
- NCT04641624 — sFlt- 1, PIGF, and Niacin Levels in Women With Premature Ovarian Insufficiency · completed
- NCT04588220 — Melatonin, Soluble Urokinase-type Plasminogen Activator Receptor, and Orosomucoid 2 Levels in PPROM · unknown
- NCT04523233 — Metals/Vitamins Levels in NTD · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04532021 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cengiz Gokcek Women's and Children's Hospital
- Last refreshed: 12 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04532021.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing