Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester Abortion
Condition: Medical; Abortion, Fetus
Study type: Observational

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

Detailed 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.
    

Intervention name(s): fetal fibronectin measurement
Intervention type(s): Other
Intervention description(s): 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.
Observational model: Case-Only
Time perspective: Prospective
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