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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000483550
• Date of registration: 15/05/2015
• Prospective Registration: No
• Primary sponsor: women health hospital of assuit university
• Public title: Buccal versus Vaginal (200 microgram) Misoprostol for Second Trimester Abortion Termination
• Scientific title: Clinical randomized trial to compare efficacy and safety of vaginal and buccal misoprostol in second trimester abortion due to intrauterine fetal death
• Date of first enrolment: 17/07/2012
• Target sample size: 180
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000483550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Type of endpoint: Safety/efficacy;

Countries of recruitment

Egypt

Contacts

• Name: Dr Adel Gamal Osman

• Name: Dr Mohammad Sayed Abdellah

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: 42 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Missed Abortion;Intrauterine fetal death;
Missed Abortion
Intrauterine fetal death

Reproductive Health and Childbirth - Abortion

Intervention(s)

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 Alsto

Primary Outcome(s)

The primary outcome measure is the induction interval, the time from the initial misoprostol dose until complete fetal expulsion.[at time of complete fetal expulsion ]

Secondary Outcome(s)

Incidence of side effects of misoprostol (such as nausea, vomiting, fever, chills, diarrhea, tachycardia, and headache)[untill complete fetal expulsion]

number of misoprostol doses[till time of expulsion for maximum 24 hours]

Secondary ID(s)

none

Source(s) of Monetary Support

women health hospital of assuit university

Secondary Sponsor(s)

Mohammad Sayed Abdellah

Ethics review

Status: Approved
Approval date:
Contact:

national research center of egypt