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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02694198
Enrollment
135
Registered
2016-02-29
Start date
2015-09-30
Completion date
2016-03-31
Last updated
2016-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical; Abortion, Fetus

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.

Interventions

OTHERfetal 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.

Sponsors

Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cervicovaginal Fetal Fibronectin Level72 hoursmean cervicovaginal fetal fibronectin level in women undergoing midtrimesteric induction of abortion
Relation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortion72 hoursDifference 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)

Countries

Egypt

Participant flow

Participants by arm

ArmCount
Mid-trimester Abortion
The population of the study comprised 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
135
Total135

Baseline characteristics

CharacteristicMid-trimester Abortion
Age, Continuous28.4 years
STANDARD_DEVIATION 4.02
Body mass index29.4 kilograms per squared meter
STANDARD_DEVIATION 2.31
gestational age in weeks19.32 weeks
STANDARD_DEVIATION 1.91
Outcome of induction of abortion
abortion in less than 24 hours
119 participants
Outcome of induction of abortion
abortion in more than 24 hours
13 participants
Outcome of induction of abortion
failed induction
3 participants
Sex: Female, Male
Female
135 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
118 / 135
serious
Total, serious adverse events
0 / 135

Outcome results

Primary

Cervicovaginal Fetal Fibronectin Level

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

Time frame: 72 hours

Population: Depending on Francesco et al., 2005 who found that Fetal fibronectin test positive in 19 among 270 (7.0%) women undergoing mid-trimester abortion. Assuming α=0.05 and confidence interval (CI)= 10.0% and by using PASS 11th release the minimal sample size is 120. With a possible 10% drop out of cases, the enrolled cases would be 135 cases.

ArmMeasureValue (MEAN)Dispersion
Mid-trimester AbortionCervicovaginal Fetal Fibronectin Level39.4 nanogram per milliliterStandard Deviation 7.9
Primary

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)

Time frame: 72 hours

ArmMeasureGroupValue (MEAN)Dispersion
Mid-trimester AbortionRelation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortionwomen aborted within 24 hours n=12939.3 nanogram per milliliterStandard Deviation 7.71
Mid-trimester AbortionRelation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortionwomen aborted in more than 24 hours or failed n=640.4 nanogram per milliliterStandard Deviation 11.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026