Trial Outcomes & Findings for Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester Abortion (NCT NCT02694198)

NCT ID: NCT02694198

Last Updated: 2016-05-16

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 135 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2016-05-16

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	135
Overall Study COMPLETED	135
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Mid-trimester Abortion n=135 Participants 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
Age, Continuous	28.4 years STANDARD_DEVIATION 4.02 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Body mass index	29.4 kilograms per squared meter STANDARD_DEVIATION 2.31 • n=5 Participants
gestational age in weeks	19.32 weeks STANDARD_DEVIATION 1.91 • n=5 Participants
Outcome of induction of abortion abortion in less than 24 hours	119 participants n=5 Participants
Outcome of induction of abortion abortion in more than 24 hours	13 participants n=5 Participants
Outcome of induction of abortion failed induction	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Mid-trimester Abortion n=135 Participants 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
Cervicovaginal Fetal Fibronectin Level	39.4 nanogram per milliliter Standard Deviation 7.9

PRIMARY outcome

Timeframe: 72 hours

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)

Outcome measures

Measure	Mid-trimester Abortion n=135 Participants 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
Relation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortion women aborted within 24 hours n=129	39.3 nanogram per milliliter Standard Deviation 7.71
Relation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortion women aborted in more than 24 hours or failed n=6	40.4 nanogram per milliliter Standard Deviation 11.2

Adverse Events

Mid-trimester Abortion

Serious events: 0 serious events

Other events: 118 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mid-trimester Abortion n=135 participants at risk 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
Surgical and medical procedures Need for surgical removal of placenta	64.4% 87/135 • Number of events 87 • All participants were closely monitored during the process of induction of abortion and over the following 24 hours following spontaneous expulsion or surgical removal of the placenta.
General disorders Shivering	3.7% 5/135 • Number of events 5 • All participants were closely monitored during the process of induction of abortion and over the following 24 hours following spontaneous expulsion or surgical removal of the placenta.
General disorders Fever	4.4% 6/135 • Number of events 6 • All participants were closely monitored during the process of induction of abortion and over the following 24 hours following spontaneous expulsion or surgical removal of the placenta.
Gastrointestinal disorders Nausea	8.9% 12/135 • Number of events 12 • All participants were closely monitored during the process of induction of abortion and over the following 24 hours following spontaneous expulsion or surgical removal of the placenta.
Gastrointestinal disorders Diarrhea	2.2% 3/135 • Number of events 3 • All participants were closely monitored during the process of induction of abortion and over the following 24 hours following spontaneous expulsion or surgical removal of the placenta.
Gastrointestinal disorders Vomiting	3.7% 5/135 • Number of events 5 • All participants were closely monitored during the process of induction of abortion and over the following 24 hours following spontaneous expulsion or surgical removal of the placenta.

Additional Information

amr ahmed mahmoud riad

Ain Shams Maternity hospital

Phone: 01005347179

Email: amr.riad@med.asu.edu.eg

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place