Table 2 Characteristics of the included RCTs

Abbasi, 2017 [11]

Bangladesh

IG: 34.17 ± 2.11

CG: 35.64 ± 2.12

Mifepristone: Single oral dose of 200 mg

Misoprostol:

Timing: 48 h after mifepristone

Dosage by GA:

GA < 34 weeks: 100 µg per dose

GA ≥ 34 weeks: 50 µg per dose

Frequency: Repeated every 6 h as needed

Maximum Dose: 600 µg

100 µg misoprostol every 6 h in the posterior fornix

IDI: Significantly shorter in the IG (10–12 h) vs. CG (24–26 h) (P < 0.001)

Misoprostol Dose: Lower in the IG (P < 0.001)

Oxytocin Use: Required in 4 cases (CG); none in the IG

Failed Induction: 2 instances in the CG and none in the IG

Maternal complications were minimal in both groups. Vomiting, diarrhea, fever (> 100 °F), chills, and rigor were noted in some cases. No reports of uterine hyperstimulation, tachysystole, hemorrhage, or DIC. Risk of fever, PPH, and hyperstimulation showed no significant differences

Agrawal, 2014 [22]

Nepal

IG: 31.5 ± 6.5

CG: 31.8 ± 6.2

Mifepristone: Single oral dose of 200 mg

Misoprostol:

Timing: Administered vaginally 24 h after mifepristone

Frequency: Vaginal misoprostol inserted every 4 h until labor or delivery

Dosage by GA:

20–28 weeks GA: 100 µg per dose

 > 28 weeks GA: 50 µg per dose

Second Course: If the first induction attempt was unsuccessful, a second course with the same dose was given after a 12-h break

Misoprostol administered vaginally into the posterior fornix

Misoprostol Doses: Significantly lower in the IG compared to the CG

Onset of Labor: Earlier in the IG; total IDI showed no significant difference

Delivery Within 24 Hours: 85.7% in the IG vs. 70% in the CG, (P = 0.07)

Oxytocin Use: More frequent in the CG

No uterine tachysystole, PPH, or coagulopathy cases were recorded in any group

Arjunan, 2017 [8]

India

IG: 34 ± 4

CG: 33 ± 4

Mifepristone: Single oral dose of 200 mg

Misoprostol:

Timing: 50 µg misoprostol every 4 h, starting 24 h after the initial dose

Maximum Doses: Up to 5 doses

Placebo with oral 50 μg of

misoprostol up to 5 doses after 24 h

Successful Delivery Within 72 Hours: 86% (31/36) in the IG vs. 78% (28/36) in the CG (P = 0.541)

Median IDI: 3.5 h (IG) vs. 4 h (CG) (P = 0.465)

Belani, 2023 [18]

India

IG: 32.42 ± 5.41

CG: 32.31 ± 4.66

Initial Treatment:

200 mg mifepristone (single dose)

After 36 Hours:

Pregnancy < 34 weeks: 100 µg oral misoprostol every 4 h

Pregnancy > 34 weeks: 50 µg oral misoprostol every 4 h

Maximum: 4 doses

Oral Misoprostol:

Pregnancy < 34 weeks: 100 μg every 4 h

Pregnancy > 34 weeks: 50 μg every 4 h

Maximum: 4 doses

ILI: 2.54 ± 1.99 h (IG) vs. 7.24 ± 6.42 h (CG) (p < 0.0001)

IDI: 9.22 ± 8.45 h (IG) vs. 15.47 ± 11.47 h (CG) (p < 0.0001)

Oxytocin augmentation needed: 10% (intervention group) vs. 40% (control group) (p = 0.033)

Mild adverse effects (vomiting, loose stools, hyperthermia) were observed in both groups with no significant difference (p > 0.05)

Chaudhuri, 2015 [19]

India

IG: 32.5 ± 6.7

CG: 32.1 ± 6.0

Initial Treatment:

200 mg oral mifepristone (single dose)

After 36–48 Hours:

GA < 26 weeks: 100 µg vaginal misoprostol every 6 h (up to 4 doses)

GA ≥ 26 weeks: 50 µg vaginal misoprostol every 4 h (up to 6 doses)

Placebo and vaginal misoprostol:

GA < 26 weeks: 100 µg every 6 h (up to 4 doses)

GA ≥ 26 weeks: 50 µg every 4 h (up to 6 doses)

Successful Delivery:

IG: 92.5% (49 out of 53)

CG: 71.2% (37 out of 52)

P-value: 0.001

IDI:

IG: 9.8 h

CG: 16.3 h

P-value: < 0.001

Retained placenta occurred in 2 women (IG) and 1 (CG). No major complications (e.g., hemorrhage or sepsis) were reported. Shivering was more frequent with misoprostol alone (19.2% vs. 7.5% with mifepristone + misoprostol), but the difference was not significant (P = 0.09).”

Ekoh, 2024 [17]

Nigeria

IG: 31.50

CG: 31.77

Initial Treatment:

200 mg oral mifepristone (single dose)

After 24 Hours:

50 μg vaginal misoprostol

Additional Doses:

Misoprostol every 6 h until adequate uterine contractions (3–5 contractions in 10 min) were achieved

Oral placebo, followed by the same misoprostol regimen

IDI:

IG: 18.78 ± 6.51 h

CG: 37.10 ± 10.10 h

P-value: < 0.001

Misoprostol dose for labor induction:

Lower in the IG (P < 0.001)

Oxytocin augmentation:

Lower in the IG (P < 0.01)

There was no significant difference in induction complications, including hyperstimulation, postpartum hemorrhage, retained placenta, and uterine rupture, between the groups

Modak, 2018 [16]

India

IG: 32.95 ± 2.64

CG: 33.14 ± 2.61

Initial Treatment: 200 mg oral mifepristone (single dose)

After 24 h: 50 µg intravaginal misoprostol

Additional Doses: 50 µg intravaginal misoprostol every 6 h

Maximum: 5 doses

50 µg intravaginal misoprostol every 6 h

Maximum: 5 doses

Successful Delivery Within 24 Hours:

IG: 94%, CG: 81%

Difference: 12.95% (95% CI: 1.07%− 24.83%)

IDI:

IG: 12.45 h (95% CI: 10.86 h- 14.04 h). CG: 20.25 h (95% CI: 18.28 h- 22.21 h). P-value: 0.0001

Average Misoprostol Dose:

IG: 2.41 ± 1.19 doses. CG: 3.67 ± 1.07 doses. P-value: 0.0001

Shivering occurred in 8.77% of the misoprostol-only group and 3.17% of the combination group, with no statistically significant difference (P = 0.193)

Sharma, 2011 [15]

India

IG: 33.35 ± 3.63

CG: 34.60 ± 3.94

Mifepristone: 200 mg oral dose

Misoprostol:

Timing: Oral Dose: misoprostol given 36 h after mifepristone

GA < 37 weeks: 100 µg per dose

GA ≥ 37 weeks: 50 µg per dose

Frequency: Administered every 3 h until active labor

Maximum Doses: Up to 4 doses

Pregnancy < 37 weeks: 100 μg oral misoprostol every 3 h

Maximum: 4 doses

Pregnancy > 37 weeks: 50 μg oral misoprostol every 3 h

Maximum: 4 doses

Delivery with Mifepristone Alone: 60% of women in the IG

IDI: 6.72 ± 3.34 h (IG) vs. 11.81 ± 6.33 h (CG)

Misoprostol Doses: Significantly fewer doses required in the IG

Side effects in the intervention group were minimal, with only two women experiencing vomiting and diarrhea. In the misoprostol group, nausea (10.75%), vomiting (25%), headache (14.29%), diarrhea (7.15%), and fever (17.86%) were reported

Sindhuri, 2020 [20]

India

IG: 34.0 ± 3.75

CG: 33.4 ± 4.10

Mifepristone: 200 mg oral dose, given as outpatient medication, regardless of GA

Misoprostol:

Timing: Administered 24 h after mifepristone

GA 24–34 weeks: 200 µg vaginal misoprostol

GA > 34 weeks: 100 µg vaginal misoprostol

Misoprostol: 200 μg for GA 24–34 weeks and 100 μg vaginally for GA over 34 weeks

Misoprostol Doses: 4 doses (CG) vs. 1 dose (IG) (P < 0.001)

IDI:

IG: 48.27% (3.3–5 h) and 51.72% (5–8.3 h)

CG: 57.1% (11.6–16.6 h) (P < 0.001)

IDI decreased with increasing GA

Gastrointestinal side effects were observed in 8 patients in the CG, with 3 having fever, 2 experiencing vomiting, chills, and rigor, and 1 with diarrhea. In the IG, 3 patients reported side effects, with 2 having vomiting and 1 with fever

Talasani, 2018 [21]

India

IG: 31.1 ± 4.3

CG: 30.97 ± 4.41

Mifepristone: 200 mg oral dose

Misoprostol:

Timing: Misoprostol administered 24 h after mifepristone

GA 24–26 weeks: 100 µg every 6 h (up to 4 doses)

GA > 26 weeks: 25–50 µg every 4 h (up to 6 doses)

GA 24–26 weeks: 100 μg misoprostol every 6 h

Maximum: 4 doses

GA beyond 26 weeks: 25–50 μg misoprostol every 4 h

Maximum: 6 doses

IDI: 10 h (IG) vs. 16.3 h (CG) (P = 0.007)

Misoprostol Dose: 1.87 (IG) vs. 2.67 (CG) (P = 0.008)

The regimen caused mild gastrointestinal side effects, including nausea, vomiting, and diarrhea, in 6.7% of cases in the IG and 13.4% in the CG. Complications such as uterine tachysystole or hyperstimulation were not encountered, as women were closely monitored after induction