Abortion, Second Trimester, Catheters, Misoprostol, Pregnancy Trimester, Second
Conditions
Keywords
misoprostol, transcervical balloon catheter, second trimester, induced abortion
Brief summary
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).
Detailed description
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.
Interventions
DRUGMisoprostol
400 micro grams misoprostol administered vaginally followed every 6 hours by 400 micro grams orally until complete expulsion
DEVICEMisoprostol/Transcervical catheter
Foleys' catheter introduced into the cervix and inflated with 30 ml. of fluid; weighted traction applied by using a 1000 ml fluid-filled bag
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours. The second group will receive the same regimen, but in addition will have a transcervical balloon (Foleys') catheter that will be inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix. The target sample size is 108 cases randomized in a ratio of 1:1 using a computer-generated random sequence, allocation will be concealed in sealed, opaque consecutively-numbered envelopes. Women are counseled about the procedure, consenting women will be randomly assigned to one of the two groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induction-expulsion interval | 48 hours from starting intervention | The duration from the administration of the first misoprostol dose vaginally till complete expulsion of the uterine contents; complete uterine emptiness will be confirmed by ultrasonographic assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total required doses of misoprostol | 48 hours from starting induction | The total amount of misoprostol used per participant during the procedure |
| The need for surgical interventions | 1 week from starting induction | The number of participants requiring any surgical intervention under anesthesia to complete uterine emptiness |
Countries
Egypt
Contacts
Primary ContactAlaa Elfeky, Professor
Outcome results
None listed