Oral dydrogesterone for prevention of miscarriage in threatened miscarriage: a randomized, double-blind, placebo-controlled trial

Figures & data

Figure 1. Consort flow diagram.

Table 1. Baseline characteristics (n = 100).

	Dydrogesterone (n = 50)	Placebo (n = 50)	p value
Age (years)	30.5 ± 5.2	31.2 ± 5.4	0.50
Multiparities	18 (36%)	21 (42.0%)	0.538
Previous miscarriage	15 (30%)	8 (16%)	0.096
Gestational age (weeks)	11.3 ± 3.6	10.4 ± 3.8	0.262
Trimester			0.648
First trimester	38 (76%)	36 (72%)
Second trimester	12 (24%)	14 (28%)
Body mass index (kg/m^2)	23.9 ± 6.2	24.5 ± 5.0	0.584

Data were presented as mean ± standard deviation or n (%).

Table 2. Rate of continuation of pregnancy beyond 20 weeks of gestation and live birth (n = 100).

	Dydrogesterone (n = 50)	Placebo (n = 50)	Relative risk (95%confidence interval)	p value
Ongoing pregnancy beyond 20 weeks	45 (90.0%)	43 (86.0%)	1.19 (0.71–2.02)	0.538
Live birth	45 (90.0%)	43 (86.0%)	1.19 (0.71–2.02)	0.538

Data were presented as n (%).

Table 3. Obstetric and neonatal outcomes (n = 88).

	Dydrogesterone (n = 45)	Placebo (n = 43)	p value
Gestational age at delivery (weeks)	37.6 ± 1.5	37.9 ± 1.7	0.302
Birth weight (grams)	2891.0 ± 425.7	3014.1 ± 462.7	0.197
Route of delivery			0.468
Normal labor	17 (37.8%)	20 (46.5%)
Cesarean section	27 (60.0%)	23 (53.5%)
Forceps extraction	1 (2.2%)	0 (0%)
Preterm birth	7 (15.6%)	8 (18.6%)	0.704
Placenta previa	1 (2.2%)	1 (2.3%)	1.000
Placental abruption	0 (0%)	0 (0%)	NA
Fetal growth restriction	1 (2.2%)	1 (2.3%)	1.000
Neonatal complications	4 (8.8%)	2 (4.7%)	0.676
Respiratory distress syndrome	3 (6.7%)	2 (4.7%)
Intraventricular hemorrhage	0 (0%)	0 (0%)
Necrotizing enterocolitis	0 (0%)	0 (0%)
Death	1 (2.2%)	0 (0%)	1.000
Mean Apgar score at 1 minute	8.7 ± 1.1	8.7 ± 0.8	0.966
Mean Apgar score at 5 minutes	9.7 ± 0.8	9.8 ± 0.5	0.789

Data were presented as mean ± standard deviation or n (%).

Table 4. Duration of bleeding, drug use, side effects, compliance, and satisfaction (n = 100).

	Dydrogesterone (n = 50)	Placebo (n = 50)	p value
Total duration of bleeding (days)			0.621
≤ 7 days	40 (80.0%)	39 (78.0%)
8-14 days	6 (12.0%)	8 (16.0%)
≥ 15 days	4 (8.0%)	3 (6.0%)
Total duration of drug use (days)	10.9 ± 6.9	10.9 ± 6.1	0.951
Total amount of drug taken (tablets)	21.5 ± 13.8	21.3 ± 12.0	0.945
Side effects	27 (54%)	24 (48%)	0.548
Headache	10 (20.0%)	8 (16.0%)	0.603
Nausea and/or vomiting	23 (46.0%)	19 (38.0%)	0.418
Good drug compliance	45 (90.0%)	47 (94.0%)	0.715
Good satisfaction with drug use	48 (96.0%)	49 (98.0%)	1.000

Data were presented as mean ± standard deviation or n (%).

Data availability statement

The data that support the findings of this study are available on request from the corresponding author, VP. The data are not publicly available due to their containing information that could compromise the privacy of research participants.