4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.

4.1

A non‑randomised comparative study of 78 women with a partial septate uterus and a history of recurrent miscarriage reported miscarriage rates of 22% (8 out of 37) after hysteroscopic metroplasty and 50% (9 out of 18) with expectant management (p<0.05), at a mean follow‑up of 11 months. A non‑randomised comparative study of 48 women with a septate uterus and a history of recurrent miscarriage reported miscarriage rates for the first pregnancy after enrolment of 18% (4 out of 22) after hysteroscopic metroplasty and 64% (9 out of 14) with expectant management (p<0.001), at a mean follow‑up of 36 months. A case series of 973 women with a septate uterus and a history of recurrent miscarriage or infertility reported the pregnancy outcomes of 344 women after hysteroscopic metroplasty: 78% (268 out of 344) of women reached term, 14% (48 out of 344) of women miscarried before 12 weeks' gestation, 4% (14 out of 344) of women miscarried after 12 weeks' gestation and 14 women were still pregnant at the close of the study (follow‑up period not reported). A case series of 170 women with a partial or complete septate uterus and a history of recurrent miscarriage, preterm delivery or infertility reported that before hysteroscopic metroplasty, 92% (332 out of 363) of pregnancies ended in miscarriage compared with 13% (24 out of 186) of pregnancies after hysteroscopic metroplasty (p=0.02), at a mean follow‑up of 29 months.

4.2

A review of 2,528 women (37 studies) with a septate uterus and a history of recurrent miscarriage, infertility, spontaneous abortion or preterm delivery, that included a meta‑analysis of 2,074 women (29 studies) reported a live birth rate of 50% after hysteroscopic metroplasty (95% confidence interval [CI] 43 to 57; 19 studies, n=1,525; follow‑up period not reported). A case series of 246 women with a septate uterus and a history of recurrent miscarriage or infertility reported a live birth rate after hysteroscopic metroplasty of 60% (71 out of 129) in women with a history of recurrent miscarriage, at a mean follow‑up of 37 months; there were 11 ongoing pregnancies at the close of the study.

4.3

The non‑randomised comparative study of 78 women with a partial septate uterus and a history of recurrent miscarriage reported preterm delivery in 5% (2 out of 37) of pregnancies in women treated by hysteroscopic metroplasty and 28% (5 out of 18) in women managed expectantly (p<0.05). The non‑randomised comparative study of 48 women with a septate uterus and a history of recurrent miscarriage reported preterm delivery in 5% (1 out of 22) of pregnancies after hysteroscopic metroplasty and 7% (1 out of 14) with expectant management, for the first pregnancy after enrolment (p value not stated). The case series of 170 women with a partial or complete septate uterus and a history of recurrent miscarriage, preterm delivery or infertility reported preterm delivery in 6% (22 out of 363) of pregnancies before hysteroscopic metroplasty compared with 8% (14 out of 186) of pregnancies after hysteroscopic metroplasty (p=0.12). The case series of 246 women with a septate uterus and a history of recurrent miscarriage or infertility reported a preterm delivery rate after hysteroscopic metroplasty of 11% (14 out of 129) of pregnancies in women with a history of recurrent miscarriage.

4.4

The specialist advisers listed the key efficacy outcomes as a normal‑sized uterine cavity, pregnancy rate, reduced miscarriage rate and increased live birth rate.