Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester Abortion

NCT02694198 | Completed Results DMC

• 1 other identifier: fetal fibronectin
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester abortion.

Conditions

Medical; Abortion, Fetus

Outcome Measures

Primary Outcomes (2)

• Cervicovaginal Fetal Fibronectin Level

  mean cervicovaginal fetal fibronectin level in women undergoing midtrimesteric induction of abortion

  72 hours

• Relation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortion

  Difference between women who expulsed the fetus within 24 hours and women who expulsed the fetus in more than 24 hours as regarding cervicovaginal fetal fibronectin level (ng/ml)

  72 hours

Interventions

fetal fibronectin measurement OTHER

All patients will be put in the dorsal lithotomy position.Using a proper light source and sterile gloves, a sterile speculum free of lubricants will be placed into the vagina before vaginal examination by senior resident and the special Dacron swab from the FFN kit will be used to collect a sample of secretions from the posterior fornix. The sample should be obtained prior to collection of any vaginal wet preparations, before any cervical manipulation or cervical cultures, and if enough amount of fluid (about 2 ml) is not found, vagina will be washed with 2 ml of normal saline.The swab will be placed in sterile plastic containers which will be stored until assayed quantitatively with an Enzyme-Linked Immuno Sorbant Assay.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol

You may qualify if:

• Singleton pregnancy.
• weeks gestation..
• Missed miscarriage

You may not qualify if:

• History of pulmonary, hepatic, renal, or cardiovascular diseases.
• History of previous cesarean section and other uterine surgeries as hysterotomy and myomectomy.
• Inevitable abortion.
• Placenta covering internal os.
• History of any cervical surgery as cervical amputation, cauterization or dilatation.
• Premature rupture of membranes.
• Any vaginal bleeding.
• Contraindications for misoprostol as hypersensitivity to misoprostol, chronic adrenal insufficiency and inherited porphyrias.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams maternity hospital

Cairo, Egypt

Location

Results Point of Contact

• Title: amr ahmed mahmoud riad
• Organization: Ain Shams Maternity hospital

amr.riad@med.asu.edu.eg

01005347179

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: February 29, 2016
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 16, 2016
• Results First Posted: April 6, 2016

Record last verified: 2016-04

Locations

EG (1)