NCT04532021

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

August 21, 2020

Last Update Submit

October 8, 2020

Conditions

Preterm Premature Rupture of Membranes

Outcome Measures

Primary Outcomes (3)

  • MMP-14 levels in PPROM

    The primary outcome in these analyses will compare maternal serum matrix metalloproteinase 14, neopterin, and orosomucoid 1 concentrations in PPROM group and control group.

    1 week

  • neopterin levels in PPROM

    The other primary outcome in these analyses will compare maternal serum neopterin concentrations in PPROM group and control group.

    1 week

  • orosomucoid 1 levels in PPROM

    The primary outcome in these analyses will compare maternal serum orosomucoid 1 concentrations in PPROM group and control group.

    1 week

Secondary Outcomes (1)

  • markers levels for histological chorioamnionitis in PPROM

    1 week

Study Arms (2)

preterm premature rupture of membranes

Preterm premature rupture of membranes is the rupture of membranes during pregnancy before 37 weeks' gestation.

Diagnostic Test: matrix metalloproteinase 14, neopterin, and orosomucoid 1 measurements

control group

Healthy subjects who had 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.

Diagnostic Test: matrix metalloproteinase 14, neopterin, and orosomucoid 1 measurements

Interventions

matrix metalloproteinase 14, neopterin, and orosomucoid 1 measurementsDIAGNOSTIC_TEST

These three markers levels will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.

control grouppreterm premature rupture of membranes

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPPROM Preterm premature rupture of membranes (PPROM) is defined as the prelabor rupture of membranes before 37 weeks' gestation. Preterm PROM complicates about 1% of deliveries overall.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The investigators consecutively will be recruited 44 subjects with PPROM, and 44 healthy pregnancies will be selected for the control group.

You may qualify if:

  • Pregnant women complicated with PPROM
  • Healthy pregnant women who will be delivered at term
  • Singleton pregnancy

You may not qualify if:

  • pregnant women with any systemic condition (such as chronic hypertension, renal disease and )
  • women who have dyed their hair in the last 9 months
  • history of using any medication
  • presence of gestational hypertension or gestational diabetes
  • drug user
  • patients who had fetal congenital abnormalities or genetic syndromes
  • multiple-gestation pregnancies
  • intrauterine fetal death
  • women who had any other infection or fever
  • fetal distress at admission
  • cord prolapse
  • active labor
  • antenatal bleeding
  • cervical or uterine anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cengiz Gokcek Women's and Children's Hospital

Gaziantep, Turkey (Türkiye)

Location

Related Publications (4)

  • Ekstrom B, Berggard I. Human alpha1-microglobulin. Purification procedure, chemical and physiochemical properties. J Biol Chem. 1977 Nov 25;252(22):8048-57. No abstract available.

    PMID: 72071RESULT

  • Nergiz Avcioglu S, Demircan Sezer S, Kucuk M, Zafer E, Yuksel H, Akcan B, Turgut O. Maternal serum concentrations of s-Endoglin and IL-6 in pregnancy complicated by preterm premature membrane rupture. J Matern Fetal Neonatal Med. 2016;29(12):1957-62. doi: 10.3109/14767058.2015.1070137. Epub 2015 Aug 13.

    PMID: 26169712RESULT

  • Hawinkels LJ, Kuiper P, Wiercinska E, Verspaget HW, Liu Z, Pardali E, Sier CF, ten Dijke P. Matrix metalloproteinase-14 (MT1-MMP)-mediated endoglin shedding inhibits tumor angiogenesis. Cancer Res. 2010 May 15;70(10):4141-50. doi: 10.1158/0008-5472.CAN-09-4466. Epub 2010 Apr 27.

    PMID: 20424116RESULT

  • Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 188: Prelabor Rupture of Membranes. Obstet Gynecol. 2018 Jan;131(1):e1-e14. doi: 10.1097/AOG.0000000000002455.

    PMID: 29266075RESULT

Related Links

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 31, 2020

Study Start

August 25, 2020

Primary Completion

August 30, 2021

Study Completion

September 30, 2021

Last Updated

October 12, 2020

Record last verified: 2020-10

Locations

TU(1)