Among the complications of delivery, a major complication is prolonged non-progressing labor, which is experienced by 17 percent of mothers undergoing childbirth in Pakistan. In many such cases, the mother can benefit from some operative assistance in effecting vaginal delivery of the fetus. This assistance can be provided either by application of forceps or a vacuum device. In United States, approximately 5% of deliveries undergo operative vaginal delivery. While no such data is available for Pakistan, it is estimated that 5-10% of deliveries in Pakistan require operative assistance either in the form of forceps or a vacuum device. But since 75% of births take place at home1 the majority of mothers requiring operative assistance remain deprived of it, as both forceps and conventional vacuum devices can only be used in hospital settings. This results in avoidable maternal and newborn injuries and deaths.
Forceps require a skilled operator, can cause injuries to the mother and are non-disposable. Increasingly vacuum delivery devices have become the preferred tool for assisting in non-progressing labor or cases of fetal distress . However, the conventional vacuum devices require a complicated pumping system (either electrical or mechanical) and usually employ a non-disposable cup to fit on the baby’s head that needs to be sterilized after each use. In addition, they are very costly (~USD 300-600). All these factors make them unsuitable to be used in non-hospital settings or in remote health facilities with limited resources.
Recently, a new disposable vacuum device (Kiwi Omnicup) with disposable cup and a handheld pumping system has been developed and marketed for use. Although it is reported to be slightly less effective than the conventional vacuum devices , its simplicity and ease of use make it suitable to be used in non-hospital settings. However, its major drawback is the high cost (~200 USD). Such a high cost makes it very difficult for poor countries to adopt it as a single use item both in hospital and non-hospital deliveries.
This simple manually operated device doesn’t require electricity or an external pumping system to function. Because it can be manufactured locally at such a low cost, the device comes sterile packed and is disposed of after use; this prevents re-use and transmission of infections to the mother and the baby. It is simple enough to be used by midwives who are the main health-provider involved in deliveries in Pakistan and many other developing countries.
This study will assess the efficacy and safety of the KGVDS in assisting deliveries that require vacuum extraction. The main outcome will be the proportion of successful deliveries conducted using the KGVDS.