Prediction of Preterm Labor in Asymptomatic High Risk Women

NCT03334877 | Completed

• 1 other identifier: ZUH 50
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

Two hundred and twenty women with singleton pregnancies and risk factors for spontaneous preterm birth were included in this study. Cervico vaginal fluid sampling was undertaken for qualitative assessment of β -human chorionic gonadotropin (β-hCG) and fetal fibronectin(fFN)at 24 weeks of gestation. For qualitative assay of both b-hCG and fFN, first vaginal specimens were collected by the following method: Specimen collection A sterile Cusco speculum was introduced into the vagina; the anterior lip of the cervix was grasped with sponge forceps and a cotton-tipped swab was placed into the external part of the endocervical canal (not reaching the internal os) and then into the posterior fornix (each for at least 1 min) to obtain an adequate sample of cervico vaginal secretions. Sampling was performed before doing any cervical manipulation (digital or ultrasound examination) and before introducing any vaginal material (lubricants or medications). The Hologic Specimen Collection Kit is the only acceptable specimen collection system which can be used to collect specimens for this assay. The polyester tipped swab provided in the Specimen Collection Kit should be inserted into the vagina and lightly rotated across the posterior fornix for approximately 10 seconds to absorb the cervico vaginal secretions. Once the specimen is obtained, carefully remove the swab from the vagina and place it into the tube of buffer provided with the Specimen Collection Kit. Two Specimen Collection Device per patient were obtained; one for each assay. Label the Specimen Transport Tubes with the patient's name and any other identifying information required. All women were then followed up till delivery. Women were categorized into two arms: women who delivered preterm (before 37 completed weeks of gestation) and women who delivered at term (after 37 completed weeks of gestation).

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

• The diagnostic accuracy of qualitative level of cervico vaginal β-hCG versus fetal fibronectin

  Prediction of preterm labor in asymptomatic high risk women during antenatal care.

  From 24 weeks gestation till delivery

Study Arms (1)

β -human chorionic gonadotropin

Cervico vaginal fluid sampling was undertaken for qualitative assessment of β -human chorionic gonadotropin (β-hCG) and fetal fibronectin(fFN) at 24 weeks of gestation to predict preterm labour in asymptomatic high risk patients

Diagnostic Test: β -human chorionic gonadotropin

Interventions

β -human chorionic gonadotropin DIAGNOSTIC_TEST

Cervico vaginal fluid sampling was undertaken for qualitative assessment of β -human chorionic gonadotropin (β-hCG) and fetal fibronectin(fFN) at 24 weeks of gestation.

β -human chorionic gonadotropin

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Two hundred and twenty women with singleton pregnancies and risk factors for spontaneous preterm birth were included in this study at 24 weeks of gestation.

You may qualify if:

• There were past history of one or more spontaneous preterm labor or preterm rupture of membranes at less than 37 weeks of gestation.
• previous spontaneous second trimester miscarriage.
• previous cervical surgery (large loop excision of the transformation zone, loop electrosurgical excision procedure, laser or cone excision).
• accidental finding of a cervical length of 25 mm or less in the current pregnancy.

You may not qualify if:

• Women who reported prior sexual intercourse (within 24 hours).
• confirmed or suspected rupture of membranes.
• vaginal bleeding visible on the swab.

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 7, 2017
• Study Start: May 15, 2015
• Primary Completion: May 10, 2017
• Study Completion: October 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11