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

Medical; Abortion, Fetus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02694198
• Other study ID #: fetal fibronectin
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2016
• Last updated: February 26, 2016
• Start date: September 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: Ain Shams Maternity Hospital
• Contact: Amr A Riad, MD
• Phone: 01005347179
• Email: amr.riad[@]med.asu.edu.eg
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational

Clinical Trial Summary

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

Description:

The population of the study will comprise 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.

Before entering the study, the purpose of this work will be clearly explained and verbal consent will be obtained from all patients enrolled in the study along with routine written informed consent as governed by the hospital rules.

All participants will be subjected to:

1. History taking:

1. Personal history: age and special habits

2. Obstetric history (parity, history of abortions, previous cerculage and preterm labor). Gestational Age will be assigned by means of a combination of menstrual dating and ultrasonographic evaluation.

3. Past medical history (hypersensitivity to misoprostol, chronic adrenal insufficiency and inherited porphyrias).

4. Past history of previous cesarean section or other operations as hysterotomy and myomectomy.

2. Examination:

1. General examination: blood pressure, pulse, temperature, body weight.

2. Abdominal examination: fundal level, presence of scar of previous operations, uterine contractions.

3. Investigations:

1. Laboratory: complete blood count, c-reactive protein titre, blood group.

2. Pelvic ultrasound: to assess fetal viability, amount of liquor, gestational age, position of the placenta.

4. Assessment of vaginal fetal fibronectin:

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 fetal fibronectin kit will be used to collect a sample of secretions from the posterior fornix. The sample will be obtained prior to collection of any vaginal wet preparations, before any cervical manipulation or cervical cultures, and if enough amount of fluid (about 2ml) is not found, vagina will be washed with 2ml 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.

According to Ain Shams University Maternity Hospital protocol, termination of pregnancy will be conducted as an inpatient procedure. Termination of pregnancy will be performed using misoprostol tablets (Misotac® Sigma 200 mcg per tablet). Misoprostol tablets will be introduced by vaginal routes initially (total 800 mcg). Following the initial dose, 2 misoprostol tablets (400 mcg) will be inserted into the vagina every 4 hours to a maximum of four doses. If the woman does not have adequate contractions, within 8 hours following the last dose, the same regimen will be repeated over the following 24 hours without the loading dose.

The induction to expulsion period will be defined as the time from commencement of misoprostol until fetal expulsion without exerting any fetal traction by caregiver. After expulsion of the fetus, the patients will receive 30 units of oxytocin on 500 cc Ringer solution slowly by intravenous infusion over 30 minutes for expulsion of the placenta. Surgical evacuation will be done when indicated.

The kits used to measure level of fetal fibronectin in vaginal sample (ZYMUTEST Fibronectin kits) were provided from Hyphen BioMed corporation , France. The ZYMUTEST Fibronectin kit is an one-step enzyme immuno-assay for measuring human Fibronectin in plasma, or in any fluid where fibronectin can be present.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy.

• 14-24 weeks gestation..

• Missed miscarriage

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Medical; Abortion, Fetus

Intervention

Other:
• fetal fibronectin measurement
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.

Locations

Country	Name	City	State
Egypt	Ain Shams maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fetal fibronectin cutoff level to predict success of prostaglandins to induce miscarriage accurately	fetal fibronectin level at which a significant number of participants abort successfully within 24 hours	72 hours	Yes