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Medical Termination of pregnancy by drugs alone.
Bharati Regimen by Dr Hemant Damle and Dr Mahesh Bedekar.
Regimen Protocol Published articles Comments More Yes I want to join the regimen
Background : Mifepristone and misoprostol are approved drug combinations for use in termination of pregnancy in many countries like USA, UK, France,Sweeden and India. In some countries like USA it is approved for pregnancy up to 49 days from LMP. In countries like UK it is approved up to 20 wks of pregnancy. The manufacturers recommend 600 mgm of Mifepristone but many users have found that 200 mgm dose of Mifepristone is sufficient. The pharmacological basis for this is that dose required for blocking of progesterone in human pregnancy is 2-3 mgm/kg.
At zero hr 200 mgm of Mifepristone orally (Cost about 9 US$ or 320 Rupees)
After 48 hrs. Followed by tablet Misoprostol 200 mcg orally (Cost about 1 US$ for 4 tablets) Misoprostol is repeated orally every 4 hrs
For second trimester Patient is hospitalized at 48 hrs.
Patients counseling done regarding need/Indications for MTP
Medical history and physical examination done. USG and other investigations done.
Different methods discussed with pt. If pt opts for Bharati Regimen then informed consent is taken.
Pt is given 24/7 back up for admission to hospital with contact no and mobile no of attending doctor.
As bleeding usually starts from 48 hrs onwards Pt is asked to choose zero hr (most pt choose Thursday as zero hr so they have Weekend to tackle this problem).
Pt reports to clinic after 48 hrs and takes misoprostol orally . Second trimester pts are admitted and discharged after complete abortion. First trimester pt goes home after 2 hrs.
Pt is followed on day 3/4/7/14 by phone/at clinic. USG and other investigations done if deemed necessary.
Contraception options are discussed and offered.
Details about onset / quantity / stoppage of symptoms noted on chart.
The details are analyzed.
Results so far
Sample size 57 cases of first trimester and 28 cases of second trimester.
90% success rate in 85 pt.
Average no of misoprostol tablets used is 2.
Check curettage required in one pt of second trimester. 8 pts of first trimester.
Merits and Demerits of the New Bharati Regimen
First Trimester pt who opt for permanent sterilization do not opt as in one go both the procedures are complete.
Good for second trimester as from admission at 48 hrs to complete abortion took place within 8 hrs.
This brought good predictability regarding time of abortion and planning by doctor and pt.
While exactly opposite took place in first trimester. Though most pt started bleeding at 50 hrs the end of bleeding was prolonged and un predictable.
Dr.S.H. Raymond Head of Department of O & G Empangeni Hospital South Africa 3880 Phone: (+27) 35-9028560 Fax: (+27) 35-7922596
He said there were 35 patients and it was a "PILOT" study
R. Daniel Braun, MD
There are strange things done
From: evsono@pipeline.com [mailto:evsono@pipeline.com] Sent: Sunday, June 09, 2002 9:14 AM To: Multiple recipients of list OB-GYN-L Subject: Re: Mifepristone orally for mMTP
studies reporting 100% efficacy, 0% side-effects and 100% satisfaction suggest insufficient sample size.
At Sun, 9 Jun 2002, Dr Damle Hemant/Dr Bedekar wrote: Medical Termination of pregnancy by drugs alone. Bharati Regimen by Dr Hemant Damle and Dr Mahesh Bedekar. .
-- art fougner, md ich bin ein New Yorker
BobMertek This needs furtur statistical evaluation with more sample size. 100% success rate is too good to believe* ( our initial 35 cases had no failure !! beginners luck ? now it is reduced to 90%)
From: art fougner, md (evsono@pipeline.com) Sun Jun 9 09:11:48 2002 Braun, R. Daniel (rbraun@iupui.edu) Mon Jun 10 06:30:28 2002 Steve & Eryl Raymond (eryl@intekom.co.za) Mon Jun 10 12:07:29 2002 I agree with Art - sample size too small, and where are your controls? *( i could not imagine how to select control for MTP /cases were compared with traditional method followed in other unit) By the way "curettage" is the correct spelling, not "curratage". *(sorry corrected)
Published articles about the drug combination in second trimester
1: Br J Obstet Gynaecol 1999 Jul;106(7):706-10
Nonsurgical mid-trimester termination of pregnancy: a review of 500 consecutive
cases.
Ashok PW, Templeton A.
Department of Obstetrics and Gynaecology, University of Aberdeen, Aberdeen
Maternity Hospital, UK.
OBJECTIVE: To assess the effectiveness of a regimen comprising mifepristone
followed by a combination of the vaginal and oral administration of misoprostol
for mid-trimester medical termination of pregnancy. DESIGN: Retrospective
analysis of prospectively collected data in women undergoing mid-trimester
medical termination of pregnancy. SETTING: Aberdeen Royal Infirmary, Scotland.
SAMPLE: A consecutive series of 500 women with pregnancies of 13-21 weeks of
amenorrhea undergoing legally induced abortion in one Scottish NHS hospital.
METHODS: Each woman received a single oral dose of mifepristone 200 mg and 36-48
h later vaginal misoprostol 800 microg. Three hours following the first dose of
misoprostol, 400 microg doses were administered orally at three hourly
intervals, to a maximum of four doses. Success was defined as abortion occurring
with five doses of prostaglandin, or within 15 h of administration of the first
dose of prostaglandin. RESULTS: Ninety-seven percent aborted successfully. The
median dose of misoprostol required was 1200 microg and the median
induction-to-abortion interval after first prostaglandin administration was 6.5
h. The median number of doses of misoprostol required to induce abortion, and
the induction-to-abortion interval, was statistically significantly higher among
women at gestations 17-21 weeks than among those at 13-16 weeks (P = 0.0001). A
total of 9.4% required surgical evacuation of the uterus under general
anaesthesia and 66.4% of the women were managed as day cases. CONCLUSIONS: The
combination of oral mifepristone 200 mg followed by vaginally and orally
administered misoprostol provides a noninvasive and effective regimen for second
trimester termination of pregnancy.
PMID: 10428528 [PubMed - indexed for MEDLINE]
1: Acta Obstet Gynecol Scand 2000 Aug;79(8):702-6
Termination of second trimester pregnancy with mifepristone and gemeprost. The
clinical experience of 197 consecutive cases.
Gemzell-Danielsson K, Ostlund E.
Department of Woman and Child Health, Karolinska Hospital, Stockholm, Sweden.
BACKGROUND: Earlier controlled clinical trials have demonstrated that combined
treatment with the antiprogestagen, mifepristone and a suitable prostaglandin
reduce the induction to abortion time in second trimester abortion. The aim of
this study was to describe the results of the 197 consecutive second trimester
terminations performed in routine clinical practice at our Department from 1996
to 1998. METHODS: The report is based on 197 consecutive second trimester
abortions including live pregnancies and missed abortions, carried out in 192
women. The women were treated with 600 mg mifepristone followed 24 to 48 hours
later by 1 mg gemeprost administered every 6 hours four times. If abortion had
not occurred, 1 mg gemeprost was administered every 3 hours for the next 12
hours. After expulsion of the fetus a surgical evacuation of the uterus was
routinely performed up to 18 weeks gestation and thereafter when needed. The
induction to abortion time was defined as the interval between the insertion of
the first gemeprost pessary and expulsion of the fetus. RESULTS: The median
abortion time was 9.0 (1.4-40.5) hours for primigravidae and 7.2 (0-152.5) hours
for multigravidae. The medium number of gemeprost pessaries to induce abortion
was two and all except seven women aborted within 24 hours. Significantly more
abortions occurred before 6, 7 and 8 hours in multigravidae than among
primigravidae. The induction to abortion interval was also significantly shorter
for nulliparous than for parous women. Except for one case of heavy bleeding, no
serious complications occurred. CONCLUSION: The study confirms the efficacy and
safety of mifepristone, together with gemeprost, for termination of second
trimester pregnancy when routinely used in the clinic.
Publication Types:
Clinical Trial
PMID: 10949238 [PubMed - indexed for MEDLINE]
1: Zhonghua Fu Chan Ke Za Zhi 1999 May;34(5):268-71
[Termination of 10-16 weeks's gestation with mifepristone plus misoprostol: a
multicentre randomized clinical trial]
[Article in Chinese]
Cheng L.
Shanghai Institute of Fasmily Planning Technical Instruction, Shanghai 200030.
OBJECTIVES: To find out the optimal regimen of mifepristone in combination with
misoprostol for termination of 10-16 week's gestation. METHODS: A randomized
comparative study in 2,007 women requesting medical abortion at 10-16 week's
gestation from 24 hospitals was conducted in Shanghai. Women were randomly
divided into 4 groups. In group I (n = 511) women took mifepristone 75 mg orally
per day for 2 days (total dose 150 mg), and 48 hours later misoprostol 0.6 mg
orally every 3-4 hours for 3 times; group II (n = 491) mifepristone 100 mg
orally per day for 2 days (total dose 200 mg) and 48 hours later same dose of
misoprostol were taken as in group I; group III (n = 519) same dose of
mifepristone as in group I and 48 hours later misoprostol given vaginally every
12 hours for 3 times; group IV (n = 486) same dose of mifepristone as in group
II and 48 hours later same dose of misoprostol vaginally as in group III.
RESULTS: The successful abortion rate from group I to group IV were 88.6%,
89.4%, 90.9% and 94.0% respectively. The successful abortion rate of group IV
was higher than that in group I and II with significant differences (P < 0.05).
The average dose of misoprostol by vaginal route in successful case was much
lower than that by oral (P < 0.01), and the rate of side effects was much lower
by vaginal too. CONCLUSION: Mifepristone taken 200 mg orally plus misoprostol
vaginally is an optimal method for termination of 10-16 week's gestation.
Publication Types:
Clinical Trial
Multicenter Study
Randomized Controlled Trial
PMID: 11326930 [PubMed - indexed for MEDLINE]
1: Eur J Obstet Gynecol Reprod Biol 1996 Dec 27;70(2):159-63
Termination of 2nd and 3rd trimester pregnancies with mifepristone and
misoprostol.
Jannet D, Aflak N, Abankwa A, Carbonne B, Marpeau L, Milliez J.
Department of Obstetrics and Gynecology, Saint-Antoine Hospital, Paris, France.
OBJECTIVE: The purpose of this study was to evaluate our use of the association
of mifepristone and misoprostol for terminating second and third trimester
pregnancies. STUDY DESIGN: One hundred and six patients undergoing termination
of pregnancy between January 1993 and June 1995 in our center were studied. Each
patient received 600 mg of mifepristone followed 24 h later by 400 microgrammes
of misoprostol every 6 h. RESULTS: The average interval from the first
administration of misoprostol to expulsion was 12.5 +/- 7.5 h (interval markedly
decreased to 9.6 +/- 6.3 h in cases of intrauterine fetal death). CONCLUSION:
The efficacy of the association of mifepristone and misoprostol is comparable
with that of current regimens with grealer ease of utilization and at a much
lower cost.
PMID: 9119097 [PubMed - indexed for MEDLINE]
1: Eur J Obstet Gynecol Reprod Biol 2001 Mar;95(1):52-4
Second trimester termination of pregnancy for fetal anomaly or death: comparing
mifepristone/misoprostol to gemeprost.
le Roux PA, Pahal GS, Hoffman L, Nooh R, El-Refaey H, Rodeck CH.
Department of Obstetrics and Gynaecology, University College Hospital, London,
UK. pleroux@iafrica.com
OBJECTIVE: To assess the effect of changing the regimen for second trimester
induction of labour from gemeprost to mifepristone/misoprostol. DESIGN and
SETTING: A retrospective study at a university teaching hospital over the 5-year
period 1993-1997. SUBJECTS, METHODS and REGIMENS: 68 patients, 34 in the
gemeprost group and 34 in the mifepristone/misoprostol group. The gemeprost
group received 1mg vaginally every 3h to a maximum of five doses. The
mifepristone/misoprostol group were pre-treated with 600 mg mifepristone orally
followed by 800 microg misoprostol vaginally and then 400 microg orally every 3h
to a maximum of four oral doses. MAIN OUTCOME MEASURES: Induction to abortion
interval; delivery within 24h. RESULTS: The mifepristone/misoprostol group had a
lower induction to abortion interval compared to the gemeprost group (median
8.9h versus 19.8h, respectively, p<0.01). The mifepristone/misoprostol regimen
was more successful than the gemeprost regimen; 94% versus 68%, respectively,
aborted without extra medical or surgical intervention, p=0.02. There were no
significant differences in side effects, analgesia requirements or complications
between the two groups. Three patients with previous Caesarean sections had a
ruptured uterus; two from the gemeprost group and one from the
mifepristone/misoprostol group. CONCLUSIONS: The new mifepristone/misoprostol
regimen was more effective in second trimester induction of labour. Induction of
labour with misoprostol or gemeprost should be used with care in patients with a
previous Caesarean section.
PMID: 11267720 [PubMed - indexed for MEDLINE]