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Trial registered on ANZCTR


Registration number
ACTRN12615000483550
Ethics application status
Approved
Date submitted
16/01/2015
Date registered
15/05/2015
Date last updated
15/05/2015
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 285987 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Missed Abortion 293932 0
Intrauterine fetal death 293935 0
Condition category
Condition code
Reproductive Health and Childbirth 294235 294235 0 0
Abortion

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290963 0
Treatment: Drugs
Comparator / control treatment
active control which is the buccal group
Control group
Active

Outcomes
Primary outcome [1] 294039 0
The primary outcome measure is the induction interval, the time from the initial misoprostol dose until complete fetal expulsion.
Timepoint [1] 294039 0
at time of complete fetal expulsion
Secondary outcome [1] 312390 0
Incidence of side effects of misoprostol (such as nausea, vomiting, fever, chills, diarrhea, tachycardia, and headache)
Timepoint [1] 312390 0
untill complete fetal expulsion
Secondary outcome [2] 314444 0
number of misoprostol doses
Timepoint [2] 314444 0
till time of expulsion for maximum 24 hours

Eligibility
Key inclusion criteria
1-Women who are pregnant between 13 and 27 weeks.
2- Termination of pregnancy is indicated due to intrauterine fetal death.
Minimum age
18 Years
Maximum age
42 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample Size Calculation
According to a recent study the median time to expulsion in the vaginal misoprostol and buccal misoprostol groups was 12 and 15 hours respectively with difference 3 hours in time interval
A power calculation estimated that in order to detect an effect size of 0.3 of the regression of time interval of abortion with misoprostol via vaginal compared to buccal route among women indicated for abortion in the second trimester of pregnancy with a p value < 0.05 and 95% power, a sample size of 180 patients (90 for each group) is needed. G*Power software was used for sample size calculation

Analysis of the data was performed by SPSS, version 8 for windows (10). Categorical and ordinal data were presented as ratios, whereas continuous data were presented as means + standard deviation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6596 0
Egypt
State/province [1] 6596 0

Funding & Sponsors
Funding source category [1] 290576 0
Hospital
Name [1] 290576 0
women health hospital of assuit university
Address [1] 290576 0
egypt- assuit city -assuit university street -assuit university -women health hospital -postcode 71111
Country [1] 290576 0
Egypt
Primary sponsor type
Hospital
Name
women health hospital of assuit university
Address
egypt- assuit city -assuit university street -assuit university -women health hospital -postcode 71111
Country
Egypt
Secondary sponsor category [1] 289264 0
Individual
Name [1] 289264 0
Mohammad Sayed Abdellah
Address [1] 289264 0
egypt- assuit city -assuit university street -assuit university -women health hospital -postcode 71111
Country [1] 289264 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292217 0
national research center of egypt
Ethics committee address [1] 292217 0
Address
El Buhouth St., Dokki, Cairo, Egypt.
postcode 73333
Ethics committee country [1] 292217 0
Egypt
Date submitted for ethics approval [1] 292217 0
Approval date [1] 292217 0
02/06/2012
Ethics approval number [1] 292217 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53146 0
Dr Mohammad Sayed Abdellah
Address 53146 0
EGYPT - ASSUIT CITY - Assuit University Street - Assuit University - Women health hospital - postal code 71111
Country 53146 0
Egypt
Phone 53146 0
+20 1006801036
Fax 53146 0
Email 53146 0
msayed21@yahoo.com
Contact person for public queries
Name 53147 0
Dr Adel Gamal Osman
Address 53147 0
EGYPT - ASSUIT CITY - Assuit University Street - Assuit University - Women health hospital - postal code 71111
Country 53147 0
Egypt
Phone 53147 0
+201122281431
Fax 53147 0
Email 53147 0
adelgamal683@yahoo.com
Contact person for scientific queries
Name 53148 0
Dr Mohammad Sayed Abdellah
Address 53148 0
EGYPT - ASSUIT CITY - Assuit University Street - Assuit University - Women health hospital - postal code 71111
Country 53148 0
Egypt
Phone 53148 0
+20 1006801036
Fax 53148 0
Email 53148 0
msayed21@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary