A DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED TRIAL OF POSTNATAL NORETHISTERONE ENANTHATE - THE EFFECT ON POSTNATAL DEPRESSION AND SERUM HORMONES

Objectives To determine the effect of postnatal administration of the long-acting progestogen contraceptive, norethisterone enanthate, on po stnatal depression and on serum hormone concentrations, and their asso ciation with depression.Design Double-blind randomised placebo-control led trial. Setting A tertiary care hospital in Johannesburg, South Afr ica. Population Postnatal women using a non-hormonal method of contrac eption (n = 180). Methods Random allocation within 48 hours of deliver y to norethisterone enanthate by injection, or placebo. Main outcome m easures 1. Depression scores in the three months postpartum as rated b y the Montgomery-Asberg Depression Rating Scale (MADRS) and the Edinbu rgh Postnatal Depression Scale (EPDS); 2. serum 17 beta-oestradiol, pr ogesterone, testosterone and the 17 beta-oestradiol:progesterone ratio at six weeks postpartum. Results There was a chance excess of caesare an section deliveries in the progestogen group. Mean depression scores were significantly higher in the progestogen group than in the placeb o group at six weeks postpartum (mean MADRS score 8.3 vs 4.9; P = 0.01 11; mean EPDS score 10.6 vs 7.5; P = 0.0022). Mean serum 17 beta-oestr adiol and progesterone concentrations were significantly lower in the progestogen group compared with the placebo group at six weeks postpar tum. There were no correlations between any of the hormone parameters and depression at six weeks except in the formula feeding subgroup of the placebo group, where formula feeding and 17 beta-oestradiol concen trations were positively associated with depression. Conclusions Long- acting norethisterone enanthate given within 48 hours of delivery is a ssociated with an increased risk of developing postnatal depression an d causes suppression of endogenous ovarian hormone secretion.