Misoprostol for primary versus secondary prevention of postpartum haemorrhage: a cluster-randomised non-inferiority community trial.
OBJECTIVE
To assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis.


METHODS
A cluster-randomised non-inferiority community trial.


METHODS
Health sub-centres and home deliveries in the Bijapur district of Karnataka, India.


METHODS
Women with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study.


METHODS
Auxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.


METHODS
Postpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention.


RESULTS
Misoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference -2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).


CONCLUSIONS
Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.


CONCLUSIONS
Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis.
Gynuity Health Projects, New York, NY, USA.
S
S
Raghavan
University of Illinois at Chicago, Chicago, IL, USA.
S
S
Geller
University of California, San Francisco, CA, USA.
S
S
Miller
KLE University's Jawaharlal Nehru Medical College, Belgaum, India.
S S
SS
Goudar
Gynuity Health Projects, New York, NY, USA.
H
H
Anger
BLDE University's Sri B. M. Patil Medical College, Bijapur, India.
M C
MC
Yadavannavar
Gynuity Health Projects, New York, NY, USA.
R
R
Dabash
BLDE University's Sri B. M. Patil Medical College, Bijapur, India.
S R
SR
Bidri
BLDE University's Sri B. M. Patil Medical College, Bijapur, India.
M R
MR
Gudadinni
BLDE University's Sri B. M. Patil Medical College, Bijapur, India.
R
R
Udgiri
University of Illinois at Chicago, Chicago, IL, USA.
A R
AR
Koch
KLE University's Jawaharlal Nehru Medical College, Belgaum, India.
M B
MB
Bellad
Gynuity Health Projects, New York, NY, USA.
B
B
Winikoff
D000284:Administration, Oral; D000328:Adult; D016000:Cluster Analysis; D005240:Feasibility Studies; D005260:Female; D006700:Home Childbirth; D006801:Humans; D007194:India / Q000453:epidemiology; D008880:Midwifery / Q000193:education; D016595:Misoprostol / Q000008:administration & dosage*; D010120:Oxytocics / Q000008:administration & dosage*; D006473:Postpartum Hemorrhage / Q000517:prevention & control*; D011247:Pregnancy; D011322:Primary Prevention / Q000379:methods*; D055502:Secondary Prevention / Q000379:methods*
D010120:Oxytocics; D016595:Misoprostol
Misoprostol; postpartum haemorrhage; primary prevention; secondary prevention