Clinical trial NCT02694198: Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester Abortion
Official title: Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester Abortion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical; Abortion, Fetus
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
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

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cervicovaginal Fetal Fibronectin Level
timeFrame: 72 hours
measure: Relation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortion
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams maternity hospital
Study officials:
References: