Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy
Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy
This randomized controlled study will be performed to compare the benefits and risks
 associated with the administration of misoprostol with or without the use of a transcervical
 balloon catheter to terminate pregnancy in the second trimester (defined as gestational age
 between 14 and 28 weeks of gestation).
The study will be conducted at Ain Shams Maternity Hospital. An open-label, parallel-arm,
 randomized controlled trial between two groups; each consisting of 54 women, undergoing
 termination of pregnancy during the second trimester for various medical reasons. The first
 group will receive the standard misoprostol protocol for termination of second trimester
 pregnancy currently practiced at Ain Shams Maternity Hospital; 400 micrograms of misoprostol
 administered vaginally for the first dose, followed after 6 hours by 400 micrograms
 administered orally, repeated every 6 hours till complete expulsion of the uterine contents
 or surgical interference is decided. The second group will receive the exact same regimen,
 but will have in addition a transcervical balloon (Foleys') catheter that will be inflated
 with 30 ml. of fluid; and will have weighted traction applied to the catheter through using a
 1000 ml fluid-filled bag in order to apply continuous pressure to the cervix. The target
 sample size was calculated to be 108 cases; randomization will be in a ratio of 1:1 using a
 computer-generated random sequence. Allocation will be concealed using sealed, opaque
 consecutively-numbered envelopes. Women are counseled about the procedure, consenting women
 will thus be randomly assigned to one of the groups.
Inclusion Criteria: pregnancy in the second trimester (defined as gestational age between
 14 and 28 weeks of gestation) with a medical indication for termination of pregnancy.

 -

 Exclusion Criteria:

 -