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Buccal versus Vaginal (200 microgram) Misoprostol for Second Trimester Abortion Termination

Clinical randomized trial to compare efficacy and safety of vaginal and buccal misoprostol in second trimester abortion due to intrauterine fetal death

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000483550
Enrollment
180
Registered
2015-05-15
Start date
2012-07-17
Completion date
2013-12-27
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Aim Of The Work To compare the efficacy and safety of buccal and vaginal misoprostol in a dose of 200 microgram every 4 hours for the induction of abortion in the second trimester gestation in cases of interauterine fetal death.

Interventions

The patients were interviewed at the outpatient clinic or the delivery ward ,where full detailed history was taken and examination confirming the pregnancy and gestational age based on the last menstrual period or documented early ultrasound report. Abdominal ultrasound was performed in the clinic to determine gestational duration using femur length as parameter (Hadlock system), after having confirmed the pregnancy, the gestational age and fetal death, women were informed about the nature of th

The patients were interviewed at the outpatient clinic or the delivery ward ,where full detailed history was taken and examination confirming the pregnancy and gestational age based on the last menstrual period or documented early ultrasound report. Abdominal ultrasound was performed in the clinic to determine gestational duration using femur length as parameter (Hadlock system), after having confirmed the pregnancy, the gestational age and fetal death, women were informed about the nature of the study and of the possible risks and benefits. Informed written consent was obtained from each participant. Intervention The study had 2 treatment groups . group I received a dose of misoprostol (200 microgram)(one tablet of Misotac 200 ug ; Sigma co.,Cairo, Egypt) every 4 hours buccally (and the subject was instructed not to swallow it for one hour) till expulsion of the fetus for maximum 24 hours . Group II received a dose of moistened misoprostol (200 microgram) (one tablet of Misotac 200 ug ; Sigma co.,Cairo, Egypt) every 4 hours vaginally(tablet was put into the posterior fornix)till expulsion of the fetus for maximum 24 hours. Follow up Subjects were asked about onset and degree of pain and examined every 4 hours for blood pressure , pulse and temperature, and were examined vaginally every 4 hours to assess progress of cervical opening and presence of vaginal bleeding up to fetal expulsion . Once fetal expulsion occurred, the patient received a dose of oxytocin , 10 U in 500 mL of lactated Ringers by iv infusion till delivery of the placenta. Removal of the placenta by surgical dilatation and evacuation was performed immediately in case of heavy bleeding ,or if it was retained following fetal expulsion more than half an hour (as recorded by E Alston RM, 2012). Antibiotic therapy prescription as a part of the hospital protocol was given to all women post abortive before discharge and antibiotic plus treatment for inhibition of lactation drug was prescribed as a home treatment . hemoglobin level was done for all women before ,and 12 hours after complete expulsion. Data collection include the demographics ( the women's age, gestational age, gravidity, parity and previous misscariage) , number and timing of misoprostol doses and the induction-expulsion time interval. All women were followed for side effects such as nausea, vomiting , diarrhea and fever and reported.

Sponsors

women health hospital of assuit university
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 42 Years
Healthy volunteers
No

Inclusion criteria

1-Women who are pregnant between 13 and 27 weeks. 2- Termination of pregnancy is indicated due to intrauterine fetal death.

Exclusion criteria

1-Pregnancy before 13 weeks. 2-Pregnancy beyond 27 weeks. 3- Scarred uterus. 4-Known hypersensitivity for misoprostol. 5-Refusal of the woman to participate.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026