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 interventional procedure overview.

4.1 The review of evidence identified 1 non‑randomised comparative study. It compared women who had a balloon device inserted to disimpact an engaged fetal head before a caesarean section (n=50) against unmatched historical controls (n=124), that is, women who had a caesarean section during the second stage of labour. No other peer‑reviewed studies were identified. All outcomes were considered to relate to efficacy unless they were safety outcomes that seemed to relate directly to the balloon device.

Maternal outcomes

4.2 No maternal deaths were reported in the balloon device group whereas maternal deaths were reported in 2% (2/124) of women in the control group (p=0.51).

4.3 The mean time between uterine incision and delivery was 2.79±0.4 minutes in the balloon device group and 8.43±1.7 minutes in the control group (p<0.001).

4.4 The mean time taken to complete caesarean sections was 31.8±4.6 minutes in the balloon device group and 52.1±10.7 minutes in the control group (p<0.001).

4.5 Extensions of uterine incisions that resulted in increased operating times, blood loss, or extensions that involved 1 or more uterine arteries, the cervix, vagina or other organs, were reported in 4% (2/50) of women in the balloon device group and 15% (19/124) of women in the control group (p=0.03).

4.6 Blood loss of more than 1 litre was reported in 2% (1/50) of women in the balloon device group and 8% (10/127) of women in the control group (p=0.18). Blood transfusions were needed for 2% (1/50) of women in the balloon device group and 5% (6/127) of women in the control group (p=0.36).

Neonatal outcomes

4.7 No neonatal deaths were reported in the balloon device group whereas neonatal deaths were reported in 2% (2/124) of babies in the control group (p=0.51).

4.8 Apgar scores of less than 3 at 5 minutes were reported in 4% (2/50) of babies in the balloon device group and 3% (4/124) of babies in the control group (p=0.55).

4.9 Admission to an intensive care unit for more than 24 hours was needed for 6% (3/50) of babies in the balloon device group and 10% (12/124) of babies in the control group (p=0.33).

4.10 Seizure was reported in 2% (1/50) of babies in the balloon device group and 2% (3/124) of babies in the control group (p=0.68). No further details were provided.

4.11 Intubation was not needed in any babies in the balloon device group whereas it was needed in 4% (5/124) of babies in the control group (p=0.18).

4.12 Neonatal injury was not reported in any babies in the balloon device group whereas it was reported in 5% (6/124) of babies in the control group (p=0.12). No further details were provided.

4.13 Infection was not reported in any babies from the balloon device group whereas it was reported in 6% (7/124) of babies from the control group (p=0.09). Timing of infection was not reported.

Specialist advice

4.14 The specialist advisers listed key efficacy outcomes as the interval between uterine incision and delivery of the baby, and avoiding outcomes associated with delayed delivery, including fetal asphyxia or acidosis. They also listed avoiding trauma to the mother and her baby, including haemorrhage, vaginal laceration, cervical laceration, trauma to the maternal bladder, trauma to the lower segment of the uterus, and trauma to the fetal head (including skull fracture). Other key efficacy outcomes listed by specialist advisers were avoiding extension of the uterine incision, reducing intensive care unit or neonatal intensive care unit admission and reducing postoperative recovery times.

  • National Institute for Health and Care Excellence (NICE)