Dr. Nalini Mishra is MD, DGO, DNB (O&G), FICOG and is currently working as Professor, Department of O & G, Pt J N M Med College Raipur C. G. which is the oldest and largest teaching hospital of the state. She is a Master Trainer of Emergency Obstetric Care (EmOC). She has participated as invited Guest Faculty in international and National conferences. She was Editor-in-Chief, Souvenir North zone Yuva FOGSI 2011 held at Raipur and Co-Editor of ‘‘Obstetric Emergencies— A Handbook of Protocols and Flowcharts, for healthcare providers.’’ She has 25 Publications in various Journals and books of International and National repute. She has a keen interest in ‘‘high risk pregnancy’’ and is currently involved in many ongoing research projects.
In order to meet the Millennium Development Goals [1], we must achieve a reduction in the deaths due to postpartum haemorrhage (PPH) which is the major contributor in the developing countries [2]. As per WHO recommendations, the use of intrauterine balloon tamponade (UBT) is recommended for the treatment of PPH due to uterine atony if women do not respond to uterotonics [3]. FIGO also included uterine balloon tamponade as a recommended second-line intervention for the treatment of PPH [4]. The successful outcome of balloon tamponade is reported to be 80–100 % [5]. This high efficacy avoids surgery which is often delayed or may be unavailable thereby costing the women her life. Intrauterine balloon may also be used as a temporizing measure while awaiting transfer or to resuscitate her.
The commercially available uterine-specific devices are designed with an intrauterine drainage port but have a prohibitively high cost. Low resource settings have to rely on lower cost adaptations like condom balloon tamponade which is the most cost-effective second-line management option [6].
The condom balloon tamponade has two main disadvantages. First is not having a drainage port and therefore not letting the clinician assess the actual blood loss and second is that the thread or suture is used to tie the condom to the catheter which often causes leakage of saline.
To overcome these disadvantages, we have designed an innovative variation of condom balloon catheter and named it ‘‘CG Balloon’’ (CG is our state of Chhattisgarh in India).
It is prepared manually with all aseptic precautions as
follows (Fig. 1):
(1) Collect a Foley’s catheter of size 20–22, a packed
condom, scissors, two 20-ml syringes and 500-ml
bottle of saline in a tray.
(2) From the drainage tube of the catheter, cut two rings
of approximately 1–2 mm width (Fig. 1a).
(3) Excise (not merely incise) the bulb of the catheter
after inflating it with air (Fig. 1b).
(4) Unfold the condom over distal one-third of the catheter
(Fig. 1c).
(5) Use these rings encircling twice only (like a rubber
band in a ponytail) to secure the condom over catheter
leaving 1.5–2 cm from both the ends of condom
(Fig. 1d).
(6) Excise the tip of the Foley’s catheter and condom
together to facilitate drainage of blood (Fig. 1e).
Wash the device with antiseptic solution.
We hereby present our experience of 15 cases of its use.
In our series of 15 women, CG Balloon was used as a second-line intervention in 13 women who had atonic PPH not responding to medical means. The remaining two had other causes of haemorrhages detailed below. Women having retained placenta, uterine rupture, chorioamnionitis and known uterine anomaly were excluded. The blood loss calculation was done by pictorial blood loss assessment charts.
Women with atonic PPH were 13 and delivered between December 2014 and August 2015. The details are summarized in the Table 1. The mean age was 26.6 years, the mean gestational age was 37.2 weeks. Primi and para two women were five each and remaining three were para three. Ten (76.9 %) of them have delivered vaginally. Each of the delivery was conducted with active management of third stage of labour and as soon as atonic PPH was diagnosed, uterine massage started and uterotonic agents namely oxytocin, methyl ergometrine (if not contraindicated) and carboprost were used along with the supportive measures including intravenous fluids and blood or blood products. The mean blood loss was 1611 ml (95 % confidence interval of 1458–1764 ml). The process of making of CG Balloon started simultaneously and introduced if the bleeding was not controlled by medical method, and the interval was inversely proportional to the severity of bleeding.
The mean time interval between the diagnosis of atonic PPH and introduction of CG Balloon was 19.6 min (95 % CI 15.06–24.3 min). The shortest interval was in caesarean sections. The longest time interval was 45 min where repair of the coincidental cervical tear had to be done before placement of balloon in a case where uterus was being atonic intermittently. The shortest interval was 8 min in a case of severe atonic PPH during caesarean section not responding to any uterotonic agent.
CG balloon was inserted into the uterine cavity holding it along two fingers after grasping the cervical lips with sponge holding forceps in case of vaginal delivery. During caesarean section, it was inserted directly and the catheter shaft was pushed through the cervical canal from above, the balloon was then inflated with 20–50 ml saline before quick suturing of uterine incision. Further inflation of balloon was done to ensure the arrest the bleeding followed by closure of the abdominal wall. The balloon was inflated with saline through the bulb inflation port of the catheter by syringes in the alternating repetitive manner until the balloon conforms to the shape of uterus and the uterine fundus become firmly palpable or bleeding was controlled (whatever is earlier). Constant assessment of uterine bleeding was done while inflating the device. If bleeding persisted, inflation was continued in 20 ml aliquots. We have set an arbitrary upper limit of 500 ml, although maximum tamponade volume needed in our series was 320 ml.
Control of PPH was achieved in 12 cases in the mean time of 12.6 min (95 % CI 9.28–16.09 min). In case of continuing alarming haemorrhage, surgical intervention was resorted to. This happened in one woman (case number 9 in the Table 1) where the bleeding did not stop and the drainage port of the CG Balloon has drained 300 ml of blood while she was being shifted to operation theatre. The laparotomy was performed followed by uterine compression suturing and devascularization. She ultimately succumbed to disseminated intravascular coagulopathy. This was the only case of failure of tamponade and death in our case series.
In three cases of PPH after vaginal delivery, all primipara, the expulsion of the balloon was noticed during inflation process. This was tackled by deflating the balloon, reinserting it and packing of vagina followed by re inflation. Such expulsion was not common in multiparous women where vagina was packed with gauze pack subsequent to control of PPH. Packing prevented the condom catheter from slipping out. The catheter was then strapped to the thigh with a small piece of adhesive tape to prevent an accidental pull and inadvertent expulsion of balloon. It was connected to a urobag to measure the uterine bleeding. Bladder was catheterized. The fundus of the uterus was marked on the abdomen. Oxytocin drip started and broadspectrum antibiotic coverage was given. The woman was monitored closely for bleeding, any rise in the fundal height and vital signs.
The mean blood loss after control of PPH was 35 ml in next 12 h. In some cases, it was seen only in the connecting tube. Though the authors cannot rule out blockage of the draining aperture but since it was without any change in the fundal height or deteriorating vital parameters, we did not attempt to test the patency.
The CG Balloon was kept in situ for at least 12–24 h and deflated at a convenient hour. Deflated condom catheter was left in situ for an hour of observation with an intention to reinflate the balloon again in case of recurrence of bleeding. It was not needed in any case, and the balloon was removed along with vaginal pack. CG Balloon closely resembles uterine-specific devices after inflation (Fig. 2a, b).
A 34-year-old unbooked para four woman delivered preterm in our institute on 3rd August 2015 had profuse bleeding with well-contracted uterus. Cervix was explored in labour room but did not reveal any obvious tear of cervical lips. She was shifted to operation theatre and was explored under anaesthesia. A partial thickness laceration of about an inch was felt digitally at 2 o’clock position in the upper part of cervix, not approachable for repair. We put CG Balloon in the cervix and the bleeding was controlled in 8 min with inflation of 120 cc saline (Fig. 3). The uterine bleeding drained at the outflow tract was 40 ml in 24 h when the Balloon was removed. She was discharged well after 2 days.
A 24-year para three woman with 28-week pregnancy with bleeding placenta previa has undergone an emergency caesarean section on 6th August 2015. Uterus was well contracted after delivery of the baby and placenta, but there was significant oozing from the placental bed. CG Balloon was placed and bleeding could be controlled. Post-operative bleeding was minimal and was limited to the tubing of CG Balloon which was removed after 24 h. The woman made an uneventful recovery.
In our case series, the mean time taken in making, insertion and inflation of CG Balloon was 5–7 min. The 20-cc syringes worked best and if an assistant fills the other syringe while one is being used for inflation, tamponade can be reached real fast.
Once removed, the CG Balloon was always checked for
the rings which were cut out of Foley’s catheter and used to
fasten the condom to catheter. Neither the upper nor the
lower one ever slipped or misplaced.
We follow the protocol of achieving haemostasis within one (golden) hour of beginning of PPH. In keeping up with the policy, we go in a stepwise approach in management in a time bound manner. In case of vaginal delivery and atonic PPH, the woman is managed by medical means for 5–30 min depending upon the severity of bleeding. In unresponsive cases, balloon tamponade is inserted while the woman is prepared to be shifted to operation theatre for any surgical intervention if needed. CG Balloon by virtue of having a drainage port helps in correct estimation of any ongoing uterine bleeding and taking timely decision.
The CG Balloon successfully overcomes both the disadvantages of conventional condom balloon tamponade namely the lack of drainage inherent to it and the procedure of tying the thread which sometimes leads to leakage of saline. In our device, a uniform protocol to use the rings around only twice gives a consistent leak-proof seal with optimal tightness. It has never slipped also. Even excising the bulb takes 20–30 s.
Filling with alternating syringes helped to optimize the tamponade volume and we did achieve tamponade with much lesser volume. The rapid filling method of conventional condom balloon does not necessarily result in an increase in successful outcomes, on the contrary it may result in the inadvertent ‘‘over-distension’’ of the uterus by inflating blindly [5].
Compliance with Ethical Standard
Conflict of interest The authors declare that there is no conflict of interest.
