Abortion, Induced Clinical Trial
Official title:
A Randomized, Placebo-Controlled, Double-Blinded Study of Mifepristone in Midtrimester Termination of Pregnancy
Mid-second trimester medical terminations of pregnancy require admission to the hospital for the length of time it takes a woman to abort. The current protocol at BMC uses intra-amniotic digoxin injection the day prior to admission. The following day, the woman is admitted and given sequential doses of misoprostol until delivery occurs. The average length of time between the first dose of misoprostol and delivery is 12 hours, requiring most women to stay overnight. This is a randomized, placebo-controlled, double-blinded study designed to determine whether adding mifepristone significantly reduces the induction interval time (time between starting the first misoprostol and delivery) required for a second trimester termination.
This is a randomized, placebo-controlled, double-blinded study.
Allocation Method: Women will be randomized using a computer-run random number table.
Tablets will be placed in capsules by the pharmacy according to the randomization chart.
Blinding: Subjects will receive a capsule containing either 200 mg of mifepristone or 250 mg
Vitamin C. Neither she nor the researcher will be aware of which medication she receives.
Outcomes: The primary outcome measured will be the mean interval from first misoprostol dose
to fetal expulsion. Secondary outcomes include the proportion of women delivering within 24
hours from the first dose of misoprostol and the proportion of women with a complete
delivery not requiring additional treatment for retained placenta. We will also compare the
amount of pain medication used, as well as the length of hospital stay between the two
groups.
Inclusion criteria Inclusion criteria: · Need for second trimester induction for termination
of pregnancy · Gestational age of 18-23 weeks · At least 18 years of age or 16 years old
with parental consent No medical contraindication to the use of digoxin and misoprostol for
the purposes of inducing abortion. · Able and willing to give informed consent in English or
Spanish
Exclusion criteria Exclusion criteria: · Known allergy to mifepristone, misoprostol or
prostaglandins · Pre-existing intrauterine fetal demise · Premature preterm rupture of
membranes · IUD in place · History of chronic adrenal failure, porphyrias; or concurrent
long-term corticosteroid treatment Unable or unwilling to give informed consent in English
or Spanish
Involvement in the study will be as follows: on study day number one, all patients undergo
an ultrasound-guided amniocentesis with intra-amniotic injection of digoxin regardless of
entry into the study. Study patients will be randomized to the treatment or placebo group,
and will receive one of two similar-looking tablets containing the allocated medication. The
tablet will be swallowed in the clinic. The patient, researchers and the care providers will
be blinded to group assignment. All patients return to the hospital the the day after their
digoxin injection for induction. From this point on, the treatment of women enrolled and
those not enrolled in the study will be identical; they are admitted to the hospital and
induction for termination is begun using an initial 400mcg of misoprostol buccally. The
initial dose is followed by 200 mcg of misoprostol every six hours until delivery is
successful or 24 hours passes without delivery. Less than 5% of women require more than 24
hours of induction, and approximately 15% require extraction of the placenta if it does not
pass spontaneously after the fetus. The subjects enrolled will not differ from other
termination patients in regards to the following: 1. the number of appointments or time
required in the hospital 2. use of intra-amniotic digoxin 3. termination method;
misoprostol, 400 mg, followed by 200 mg every 6 hours 4. pain medication administration (PCA
narcotics) 5. Medical evaluation of need to use other methods of completing abortion if 24
hours has elapsed after first misoprostol dose without delivery.
Analytic Plan:
The primary outcome is the length of induction interval for termination. The Kaplan-Meier
procedure will be utilized to create a survival curve for analysis of induction to delivery
interval by time. Demographic data for each group will also be compared to assure that there
are no other differences between groups. Chi -square analysis will be used for dichotomous
variables and t-tests for continuous variables.Study Size and Power:
A power calculation was performed for time from induction to delivery using a significant
value of 0.05 and power of 80% using a survival analysis power formula. We used our previous
data to estimate the mean time of induction and then estimated a likely delta (difference
between the two treatment groups) of 35%. The number of patients needed in each group using
this calculation is 32, and therefore the total number needed is 64.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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