J Clin Gynecol Obstet

Journal of Clinical Gynecology and Obstetrics, ISSN 1927-1271 print, 1927-128X online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Gynecol Obstet and Elmer Press Inc

Journal website https://www.jcgo.org

Original Article

Volume 11, Number 2, June 2022, pages 39-46

Comparative Study Between Using Only Vaginal Misoprostol and Using Vaginal Misoprostol and Estradiol Cream for Induction of Labor: A Randomized Controlled Trial

Figure 1. CONSORT flow diagram showing the recruitment and handling of the study population during the study. NVD: normal vaginal delivery; CS: cesarean section.

**Table 1.** Comparison Between Two Studied Groups According to Baseline Characteristics
Baseline characteristics	Misoprostol group (N = 60)	Estradiol group (N = 60)	Test of significance
^aMann-Whitney test. ^bFisher’s test. ^cChi-square test. SD: standard deviation; IQR: interquartile range; ITP: idiopathic thrombocytopenic purpura; RA: rheumatoid arthritis; SLE: systemic lupus erythematosus; D&C: dilation and curettage.
Age
Range	19 - 36 years	19 - 45 years
Mean ± SD	26.2 ± 5.1	27.7 ± 6.9	0.179^a
Median (IQR)	25.5 (22.0 - 30.0)	25.0 (22.8 - 32.0)
Age category
18 - 30	41 (68.3%)	42 (70.0%)
30 - 40	19 (31.7%)	14 (23.3%)	0.092^b
> 40	0 (0.0%)	4 (6.7%)
Parity
Primiparous	22 (36.7%)	29 (48.3%)
Multipara	38 (59.6%)	31 (51.7%)	0.268^c
Gestational age
Range	36 - 41+2 weeks	36 - 42 weeks
Mean ± SD	38.9 ± 1.5	38.8 ± 1.6	0.91^a
Median (IQR)	38.9 (37.7 - 40.0)	39.0 (37.3 - 40.0)
Abortion times
Range	0 - 3 times	0 - 5 times
Mean ± SD	0.3 ± 0.7	0.4 ± 1.0	0.576^a
Median (IQR)	0.0 (0.0 - 0.0)	0.0 (0.0 - 1.0)
Medical history
Hypertension	6 (10.0%)	2 (3.3%)	0.439
Diabetes mellitus	2 (3.3%)	0 (0.0)	0.496
Other medical comorbidities
ITP	2 (3.3%)	0 (0.0)	0.305
RA	1 (1.7%)	0 (0.0)
SLE	1 (1.7%)	0 (0.0)
Thrombocytopenia	1 (1.7%)	1 (1.7%)
Surgical history
Appendectomy	2 (3.3%)	3 (5.0%)
Cholecystectomy	0 (0.0)	1 (1.7%)	0.509^b
Cystectomy	0 (0.0)	1 (1.7%)
D&C	0 (0.0)	2 (3.3%)
Tonsillectomy	4 (6.7%)	5 (8.4%)
No	54 (90.0%)	48 (80.0%)

Table 1. Comparison Between Two Studied Groups According to Baseline Characteristics

Baseline characteristics

Misoprostol group (N = 60)

Estradiol group (N = 60)

Test of significance

^aMann-Whitney test. ^bFisher’s test. ^cChi-square test. SD: standard deviation; IQR: interquartile range; ITP: idiopathic thrombocytopenic purpura; RA: rheumatoid arthritis; SLE: systemic lupus erythematosus; D&C: dilation and curettage.

Age

Range

19 - 36 years

19 - 45 years

Mean ± SD

26.2 ± 5.1

27.7 ± 6.9

0.179^a

Median (IQR)

25.5 (22.0 - 30.0)

25.0 (22.8 - 32.0)

Age category

18 - 30

41 (68.3%)

42 (70.0%)

30 - 40

19 (31.7%)

14 (23.3%)

0.092^b

> 40

0 (0.0%)

4 (6.7%)

Parity

Primiparous

22 (36.7%)

29 (48.3%)

Multipara

38 (59.6%)

31 (51.7%)

0.268^c

Gestational age

Range

36 - 41+2 weeks

36 - 42 weeks

Mean ± SD

38.9 ± 1.5

38.8 ± 1.6

0.91^a

Median (IQR)

38.9 (37.7 - 40.0)

39.0 (37.3 - 40.0)

Abortion times

Range

0 - 3 times

0 - 5 times

Mean ± SD

0.3 ± 0.7

0.4 ± 1.0

0.576^a

Median (IQR)

0.0 (0.0 - 0.0)

0.0 (0.0 - 1.0)

Medical history

Hypertension

6 (10.0%)

2 (3.3%)

0.439

Diabetes mellitus

2 (3.3%)

0 (0.0)

0.496

Other medical comorbidities

ITP

2 (3.3%)

0 (0.0)

0.305

1 (1.7%)

0 (0.0)

SLE

1 (1.7%)

0 (0.0)

Thrombocytopenia

1 (1.7%)

Surgical history

Appendectomy

2 (3.3%)

3 (5.0%)

Cholecystectomy

0 (0.0)

1 (1.7%)

0.509^b

Cystectomy

0 (0.0)

1 (1.7%)

D&C

0 (0.0)

2 (3.3%)

Tonsillectomy

4 (6.7%)

5 (8.4%)

54 (90.0%)

48 (80.0%)

**Table 2.** Comparison Between Two Studied Groups According to Maternal Complications and Fetal Outcome
	Misoprostol group (N = 60)	Estradiol group (N = 60)	Test of significance
^aChi-square test. ^bMann-Whitney test. SD: standard deviation; IQR: interquartile range; NICU: neonatal intensive care unit.
Maternal complications
Postpartum hemorrhage
No	60 (100.0%)	60 (100%)	1
Uterus rupture
No	60 (100.0%)	60 (100.0%)	1
Hyperstimulation
Yes	2 (3.3%)	1 (1.7%)	0.99
Fetal outcome
Fetal hypoxia
No	60 (100.0%)	60 (100%)	1
Meconium staining
Yes	13 (21.7%)	6 (10.0%)	0.134^a
Neonatal infection
Yes	1 (1.7%)	0 (0.0%)	0.99
First minute Apgar score			0.009^b
Mean ± SD	6.5 ± 1.0	6.9 ± 0.4
Median (IQR)	7.0 (6.0 - 7.0)	7.0 (7.0 - 7.0)
Fifth minute Apgar score			0.136^b
Mean ± SD	8.7 ± 0.5	8.8 ± 0.4
Median (IQR)	9.0 (8.0 - 9.0)	9.0 (9.0 - 9.0)
NICU admission
Yes	10 (16.7%)	6 (10.0%)	0.421^a

Table 2. Comparison Between Two Studied Groups According to Maternal Complications and Fetal Outcome

Misoprostol group (N = 60)

Estradiol group (N = 60)

Test of significance

^aChi-square test. ^bMann-Whitney test. SD: standard deviation; IQR: interquartile range; NICU: neonatal intensive care unit.

Maternal complications

Postpartum hemorrhage

60 (100.0%)

60 (100%)

Uterus rupture

60 (100.0%)

Hyperstimulation

Yes

2 (3.3%)

1 (1.7%)

0.99

Fetal outcome

Fetal hypoxia

60 (100.0%)

60 (100%)

Meconium staining

Yes

13 (21.7%)

6 (10.0%)

0.134^a

Neonatal infection

Yes

1 (1.7%)

0 (0.0%)

0.99

First minute Apgar score

0.009^b

Mean ± SD

6.5 ± 1.0

6.9 ± 0.4

Median (IQR)

7.0 (6.0 - 7.0)

7.0 (7.0 - 7.0)

Fifth minute Apgar score

0.136^b

Mean ± SD

8.7 ± 0.5

8.8 ± 0.4

Median (IQR)

9.0 (8.0 - 9.0)

9.0 (9.0 - 9.0)

NICU admission

Yes

10 (16.7%)

6 (10.0%)

0.421^a

**Table 3.** Comparison Between Two Studied Groups According to Mode of Delivery
	Misoprostol group (N = 60)	Estradiol group (N = 60)	Test of significance
^aChi-square test. NVD: normal vaginal delivery; CS: cesarean section.
Mode of delivery
NVD	31 (51.7%)	36 (60.0%)
CS	29 (48.3%)	24 (40.0%)	0.359^a
Cause of CS induction
Failed induction	14 (23.3%)	12 (20.0%)	0.825
Uterine hyperstimulation	2 (3.3%)	1 (1.7%)	1
Tachysystole	1 (1.7%)	1 (1.7%)	1
Fetal distress	12 (20.0%)	9 (15.0%)	0.631

Table 3. Comparison Between Two Studied Groups According to Mode of Delivery

Misoprostol group (N = 60)

Estradiol group (N = 60)

Test of significance

^aChi-square test. NVD: normal vaginal delivery; CS: cesarean section.

Mode of delivery

NVD

31 (51.7%)

36 (60.0%)

29 (48.3%)

24 (40.0%)

0.359^a

Cause of CS induction

Failed induction

14 (23.3%)

12 (20.0%)

0.825

Uterine hyperstimulation

2 (3.3%)

1 (1.7%)

Tachysystole

1 (1.7%)

Fetal distress

12 (20.0%)

9 (15.0%)

0.631

**Table 4.** Comparison Between Two Studied Groups According to Active Phase
	Misoprostol group (N = 60)	Estradiol group (N = 60)	Test of significance
^aChi-square test. ^bMann-Whitney test. IQR: interquartile range.
Active phase
No	28 (46.7%)	22 (36.7%)
Yes	32 (53.3%)	38 (63.3%)	0.355^a
Time needed to enter active phase (h)
Range	5.0 - 21.0	6.5 - 20.5
Median (IQR)	13.5 (11.0 - 17.0)	14.5 (11.2 - 17.9)	0.701^b
Induction delivery time (h)
Range	6.5 - 23.0	8.5 - 22.0
Median (IQR)	15.0 (12.5 - 18.6)	16.8 (13.1 - 19.8)	0.519^b

Table 4. Comparison Between Two Studied Groups According to Active Phase

Misoprostol group (N = 60)

Estradiol group (N = 60)

Test of significance

^aChi-square test. ^bMann-Whitney test. IQR: interquartile range.

Active phase

28 (46.7%)

22 (36.7%)

Yes

32 (53.3%)

38 (63.3%)

0.355^a

Time needed to enter active phase (h)

Range

5.0 - 21.0

6.5 - 20.5

Median (IQR)

13.5 (11.0 - 17.0)

14.5 (11.2 - 17.9)

0.701^b

Induction delivery time (h)

Range

6.5 - 23.0

8.5 - 22.0

Median (IQR)

15.0 (12.5 - 18.6)

16.8 (13.1 - 19.8)

0.519^b