Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review.

OBJECTIVES: To evaluate uterine tamponade devices' effectiveness for atonic refractory postpartum haemorrhage (PPH) after vaginal birth and the effect of including them in institutional protocols. SEARCH STRATEGY: PubMed, EMBASE, CINAHL, LILACS, POPLINE, from inception to January 2021. STUDY SELECTION: Randomised and non-randomised comparative studies. OUTCOMES: Composite outcome including surgical interventions (artery ligations, compressive sutures or hysterectomy) or maternal death, and hysterectomy. RESULTS: All included studies were at high risk of bias. The certainty of the evidence was rated as very low to low. One randomised study measured the effect of the condom-catheter balloon compared with standard care and found unclear results for the composite outcome (relative risk [RR] 2.33, 95% CI 0.76-7.14) and hysterectomy (RR 4.14, 95% CI 0.48-35.93). Three comparative studies assessed the effect of including uterine balloon tamponade in institutional protocols. A stepped wedge cluster randomised controlled trial suggested an increase in the composite outcome (RR 4.08, 95% CI 1.07-15.58) and unclear results for hysterectomy (RR 4.38, 95% CI 0.47-41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95% CI 0.11-1.03) and hysterectomy (RR 0.49, 95% CI 0.04-5.38) after the inclusion of the Bakri balloon. The second non-randomised study found unclear effects on the composite outcome (RR 0.95, 95% CI 0.32-2.81) and hysterectomy (RR 1.84, 95% CI 0.44-7.69) after the inclusion of Ebb or Bakri balloon. CONCLUSIONS: The effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting. TWEETABLE ABSTRACT: Unclear effects of uterine tamponade devices and their inclusion in institutional protocols for atonic refractory PPH after vaginal delivery.

A condom uterine balloon device among referral facilities in Dar Es Salaam: an assessment of perceptions, barriers and facilitators one year after implementation.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death in Tanzania. The Every Second Matters for Mothers and Babies- Uterine Balloon Tamponade (ESM-UBT) device was developed to address this problem in women with atonic uterus. The objective of this study was to understand the barriers and facilitators to optimal use of the device, in Dar es Salaam Tanzania 1 year after implementation. METHODS: Semi-structured interviews of skilled-birth attendants were conducted between May and July 2017. Interviews were recorded, coded and analyzed for emergent themes. RESULTS: Among the participants, overall there was a positive perception of the ESM-UBT device. More than half of participants reported the device was readily available and more than 1/3 described ease and success with initial use. Barriers included fear and lack of refresher training. Finally, participants expressed a need for training and device availability at peripheral hospitals. CONCLUSION: The implementation and progression to optimal use of the ESM-UBT device in Tanzania is quite complex. Ease of use and the prospect of saving a life/preserving fertility strongly promoted use while fear and lack of high-level buy-in hindered utilization of the device. A thorough understanding and investigation of these facilitators and barriers are required to increase uptake of the ESM-UBT device.

The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster-randomised trial.

OBJECTIVE: To assess the effectiveness of introducing condom-catheter uterine balloon tamponade (UBT) for postpartum haemorrhage (PPH) management in low- and middle-income settings. DESIGN: Stepped wedge, cluster-randomised trial. SETTING: Eighteen secondary-level hospitals in Uganda, Egypt and Senegal. POPULATION: Women with vaginal delivery from October 2016 to March 2018. METHODS: Use of condom-catheter UBT for PPH management was introduced using a half-day training and provision of pre-packaged UBT kits. Hospitals were randomised to when UBT was introduced. The incident rate (IR) of study outcomes was compared in the control (i.e. before UBT) and intervention (i.e. after UBT) periods. Mixed effects regression models accounted for clustering (random effect) and time period (fixed effect). MAIN OUTCOME MEASURES: Combined IR of PPH-related invasive surgery and/or maternal death. RESULTS: There were 28 183 and 31 928 deliveries in the control and intervention periods, respectively. UBT was used for 9/1357 and 55/1037 women diagnosed with PPH in control and intervention periods, respectively. PPH-related surgery or maternal death occurred in 19 women in the control period (IR = 6.7/10 000 deliveries) and 37 in the intervention period (IR = 11.6/10 000 deliveries). The adjusted IR ratio was 4.08 (95% confidence interval 1.07-15.58). Secondary outcomes, including rates of transfer and blood transfusion, were similar in the trial periods. CONCLUSIONS: Introduction of condom-catheter UBT in these settings did not improve maternal outcomes and was associated with an increase in the combined incidence of PPH-related surgery and maternal death. The lack of demonstrated benefit of UBT introduction with respect to severe outcomes warrants reflection on its role. TWEETABLE ABSTRACT: Stepped wedge trial shows UBT introduction does not reduce the combined incidence of PPH-related surgery or death.

Novel intrauterine balloon tamponade systems for postpartum hemorrhage.

INTRODUCTION: Postpartum hemorrhage is the most common cause of maternal death worldwide. Although intrauterine balloon tamponade has been widely used as an effective procedure to control atonic postpartum hemorrhage, intrauterine balloon tamponade fails to control postpartum hemorrhage in approximately one-fifth of cases. The aim of this study was to evaluate the efficacy of novel intrauterine balloon tamponade systems for postpartum hemorrhage. MATERIAL AND METHODS: We have developed two novel intrauterine balloon tamponade systems to maintain proper balloon placement. One was a shaft cover with its fixture system and the other was "the Kyoto balloon system" designed to provide direct pressure onto the upper uterine cavity. The efficacy of the intrauterine balloon tamponade systems was evaluated using a silicone three-dimensionally printed postpartum uterine cavity model. RESULTS: Measurements of balloon displacement during inflation showed that the shaft cover significantly prevented the Bakri balloon from being displaced. The residual fluid volume in the upper uterine cavity was significantly less with the Kyoto balloon system than with the Bakri balloon system, indicating the effectiveness of the Kyoto balloon for upper uterine cavity tamponade. CONCLUSIONS: These innovative intrauterine balloon tamponade systems were effective for prevention of balloon displacement and for balloon tamponade of the upper uterine cavity in a 3D-printed postpartum-specific uterine cavity model.

Intrauterine Bakri Balloon and Vaginal Tamponade Combined with Abdominal Compression for the Management of Postpartum Hemorrhage.

OBJECTIVE: This study sought to investigate the effect of Bakri balloon use and vaginal tamponade combined with abdominal compression for the management of postpartum hemorrhage (PPH). METHODS: This retrospective study reviewed cases of PPH in the International Peace Maternal and Child Health Hospital of China Welfare Institution in Shanghai, China from January 1, 2010 to December 31, 2015. A single use of the intrauterine Bakri balloon was applied in some cases, and additional vaginal tamponade combined with abdominal compression (double compression) was applied in other cases. The authors evaluated the effect of these two methods in the management of PPH. RESULTS: The Bakri balloon was used in 305 cases of intrauterine PPH, and the clinical efficacy was 93.26%. One group of study patients underwent double compression, and these patients had a better clinical efficacy rate of 96.3% (157 of 163), whereas the efficacy in cases using the Bakri balloon alone (control group) was 87.3% (124 of 142). The postoperative complication rates of these two groups were 9.4% and 8.7%, respectively. Uterine arterial embolization was performed in patients in whom Bakri balloon use failed. None of the cases resulted in a hysterectomy. CONCLUSION: Intrauterine Bakri balloon use combined with vaginal tamponade and abdominal compression is more effective in the treatment of PPH compared with Bakri balloon use alone. This method does not increase postoperative complications. Uterine atony with placenta previa or implantation may be possible reasons for noneffectiveness of Bakri balloon use.

Early usage of Bakri postpartum balloon in the management of postpartum hemorrhage: a large prospective, observational multicenter clinical study in South China.

AIM: To evaluate the success rate and protocol of the Bakri balloon for postpartum hemorrhage (PPH) in the course of a prospective observational multicenter cohort study in South China. METHODS: At 20 hospitals in South China, women with postpartum bleeding who failed to respond to the first-line conservative management and received the Bakri balloon were recruited for the study. Maternal characteristics, PPH characteristics, PPH management and outcomes in regard to the Bakri balloon use were recorded. RESULTS: A total of 472 women had a Bakri balloon tamponade and 407 (86.23%) women were enrolled (67 after vaginal delivery and 340 either during or after cesarean delivery). The success rate of the Bakri balloon in this study was 91.65% (373/407 women). During vaginal deliveries, the group with a hemorrhage >2000 mL before balloon insertion had significantly more blood loss (551.67±635.17 mL vs. 242.06±313.69 mL, P=0.039) and lower maternal hemoglobin (73±21.77 g/L vs. 92.06±19.60 g/L, P=0.029) after using Bakri balloon than the group with a hemorrhage <1000 mL. Similar data were found during cesarean deliveries. The blood loss before and after balloon insertion were significantly higher in the Bakri balloon failure group (1700±1429.88 mL before and 1209.58±1139.72 mL after using the balloon) than those in the success group [918±493.92 mL before (P=0.002) and 266.57±361.60 mL after using the balloon (P=0.001)]. CONCLUSION: Rapid diagnosis or prognosis of PPH, in combination with early usage of the Bakri postpartum balloon is more effective for the management of PPH.

Intraluminal pressure of uterine balloon tamponade in the management of severe post-partum hemorrhage.

AIM: Intrauterine balloon tamponade has been increasingly used for the management of post-partum hemorrhage (PPH) in recent years. However, data on the precise mechanisms and pressure required for the balloon tamponade are scanty in the literature. This study aims to review the intraluminal pressure (ILP) generated by the Bakri intrauterine balloon that is necessary to produce a 'positive tamponade test' during severe PPH. METHODS: This was a prospective cohort study. The ILP of the Bakri balloon was measured using a manometer after a positive tamponade test was clinically achieved during severe PPH (blood loss >1 L). The patient's blood pressure was recorded, and ultrasound scan was performed to verify the position of the balloon and the presence of forward flow in the uterine arteries. The main outcome measure is the ILP of the Bakri balloon required to achieve a positive tamponade test. RESULTS: Twenty patients were included for final analysis. The net ILP measured ranged from 67 to 92 mmHg, and this pressure was lower than the concurrent systolic pressure in all cases. Color Doppler confirmed positive forward flow in the uterine vessels in all cases. There were no differences in the pressure measured with the balloon position, and there was no relationship between the volumes of saline infused and the net pressure. CONCLUSION: A positive tamponade test in an intrauterine balloon is probably achieved by local compression pressure exerted on the vasculature of the placental bed rather than by generating an ILP exceeding systemic blood pressure or by occlusion of flow to the uterine arteries.

Condom-catheter tamponade for the treatment of postpartum haemorrhage and factors associated with success: a prospective observational study.

OBJECTIVE: To determine the outcomes and factors associated with postpartum haemorrhage (PPH) treatment with condom-catheter uterine balloon tamponade (C-UBT). DESIGN: Prospective observational study. SETTING: A secondary healthcare facility in Nigeria. POPULATION: Women with PPH refractory to first-line treatment. METHODS: Demographic and clinical characteristics were compared in women with successful and unsuccessful treatment. Univariate and multivariate logistic regression analyses were used to examine the association of these characteristics with successful treatment. MAIN OUTCOME MEASURES: The success rate of C-UBT, factors associated with success, and maternal morbidity rates in both successful and unsuccessful treatment groups. RESULTS: Overall, 203/229 (88.6%) women had successful treatment. Women with successful treatment had lower mean blood loss (1248.8 ± 701.3 ml versus 3434.6 ± 906.6 ml; P < 0.0001), lower occurrence of blood transfusion [139 (68.5%) versus 26 (100%); P < 0.0001], lower intensive care unit admission rates [5 (2.5%) versus 20 (76.9%); P < 0.0001], and lower occurrence of infectious morbidities [3 (1.5%) versus 7 (26.9%); P < 0.0001]. In the regression model with two factors, caesarean section (adjusted odds ratio, aOR 0.17; 95% confidence interval, 95% CI 0.07-0.40) was associated with lower success rates compared with vaginal delivery. In the regression model with three factors, advanced maternal age (aOR 0.31; 95% CI 0.11-0.90) and caesarean section (aOR 0.17; 95% CI 0.07-0.41) were associated with lower success rates in comparison with younger maternal age and vaginal delivery, respectively. CONCLUSIONS: Second-line PPH treatment with C-UBT is effective, and is associated with low maternal morbidity rates. Advanced maternal age and caesarean section are associated with lower success rates. TWEETABLE ABSTRACT: Condom-catheter tamponade is a useful second-line treatment modality for intractable postpartum haemorrhage.

A postpartum haemorrhage package with condom uterine balloon tamponade: a prospective multi-centre case series in Kenya, Sierra Leone, Senegal, and Nepal.

OBJECTIVE: To evaluate the effectiveness and safety of an ultra-low-cost uterine balloon tamponade package (ESM-UBT™) for facility-based management of uncontrolled postpartum haemorrhage (PPH) in Kenya, Sierra Leone, Senegal, and Nepal. DESIGN: Prospective multi-centre case series. SETTING: Facilities in resource-scarce areas of Kenya, Sierra Leone, Nepal, and Senegal. POPULATION: Women with uncontrolled postpartum haemorrhage in 307 facilities across the four countries. METHODS: A standardised ESM-UBT package was implemented in 307 facilities over 29 months (1 September 2012 to 1 February 2015). Data were collected via a multi-pronged approach including data card completion, chart reviews, and provider interviews. Beginning in August 2014, women who had previously undergone UBT placement were sought and queried regarding potential complications associated with UBT use. MAIN OUTCOME MEASURES: All-cause survival, survival from PPH, and post-UBT use complications (surgery, hospitalisation, antibiotics for pelvic infection) associated with UBT use. RESULTS: 201 UBTs were placed for uncontrolled vaginal haemorrhage refractory to all other interventions. In all, 38% (71/188) of women were either unconscious or confused at the time of UBT insertion. All-cause survival was 95% (190/201). However, 98% (160/163) of women survived uncontrolled PPH if delivery occurred at an ESM-UBT online facility. One (1/151) potential UBT-associated complication (postpartum endometritis) was identified and two improvised UBTs were placed in women with a ruptured uterus. CONCLUSIONS: These pilot data suggest that the ESM-UBT package is a clinically promising and safe method to arrest uncontrolled postpartum haemorrhage and save women's lives. The UBT was successfully placed by all levels of facility-based providers. Future studies are needed to further evaluate the effectiveness of ESM-UBT in low-resource settings. TWEETABLE ABSTRACT: Evidence for ESM-UBT as a clinically promising and safe method to arrest uncontrolled PPH and save women's lives.

Uterine Balloon Tamponade Device and Cervical Cerclage to Correct Partial Uterine Inversion during Puerperium; Case Report.

A healthy 26-year-old woman was noted to have residual uterine inversion after manual replacement of puerperal uterine inversion under general anaesthesia. This was corrected by the insertion of a balloon tamponade device. A cervical suture was applied to prevent ballooning of the device through the cervix. This little modification was immediately successful in preventing ballooning of the tamponade device. The whole idea was to overcome the need for a laparotomy. A review of the literature and the mechanism of action are discussed here.

Condom Tamponade in the Management of Primary Postpartum Haemorrhage: A Report of three cases in Ghana.

Postpartum haemorrhage is one of the major causes of maternal mortality worldwide. The leading cause of primary postpartum haemorrhage is uterine atony and active management of the third stage of labour with oxytocin is recommended for preventing primary postpartum haemorrhage. Parenteral oxytocin is also the drug of choice for medical management of postpartum haemorrhage secondary to uterine atony. Condom uterine balloon tamponade is .a low cost technique that can be used as a second-line option for treatment. We report retrospectively three cases of primary PPH secondary to uterine atony which were managed successfully with condom tamponade. Condom tamponade is effective in managing post partum haemorrhage secondary to uterine atony and we advocate for the training of all skilled attendants on how to insert the condom tamponade.

Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage.

OBJECTIVE: When uterotonics fail to cause sustained uterine contractions and satisfactory control of hemorrhage after delivery, tamponade of the uterus can be effective in decreasing hemorrhage secondary to uterine atony. STUDY DESIGN: These data are from a postmarketing surveillance study of a novel dual-balloon catheter tamponade device, the Belfort-Dildy Obstetrical Tamponade System (ebb). RESULTS: A total of 57 women were enrolled: 55 women had the diagnosis of postpartum hemorrhage, and 51 women had uterine balloon placement within the uterine cavity. This study reports the outcomes in the 51 women who had uterine balloon placement within the uterine cavity for treatment of postpartum hemorrhage, as defined by the "Instructions for Use." We further assessed 4 subgroups: uterine atony only (n = 28 women), placentation abnormalities (n = 8 women), both uterine atony and placentation abnormalities (n = 9 women), and neither uterine atony nor placentation abnormalities (n = 6 women). The median (range) time interval between delivery and balloon placement was 2.2 hours (0.3-210 hours) for the entire cohort (n = 51 women) and 1.3 hours (0.5-7.0 hours) for the uterine atony only group (n = 28 women). Bleeding decreased in 22/51 of cases (43%), stopped in 28/51 of cases (55%), thus decreased or stopped in 50/51 of the cases (98%) after balloon placement. Nearly one-half (23/51) of all women required uterine balloon volumes of >500 mL to control bleeding. CONCLUSION: We conclude that uterine/vaginal balloon tamponade is very useful in the management of postpartum hemorrhage because of uterine atony and abnormal placentation.

The use of a Rusch intrauterine balloon to cause tamponade on a severe hemorrhage in a case of endometrial cancer.

Intractable vaginal bleeding is a complication of gynecological tumors of the cervix and endometrium. The management of torrential bleeding usually requires laparotomy or laparoscopy, or less invasive techniques such as uterine artery embolization. This case report describes the use of an intrauterine Rusch balloon catheter, previously only used in the obstetric setting. This is a safe and inexpensive method of management, which does not need specific training. We also review all the current options for the management of severe bleeding as a complication of gynecological cancers.

Prioritizing investments in innovations to protect women from the leading causes of maternal death.

PATH, an international nonprofit organization, assessed nearly 40 technologies for their potential to reduce maternal mortality from postpartum hemorrhage and preeclampsia and eclampsia in low-resource settings. The evaluation used a new Excel-based prioritization tool covering 22 criteria developed by PATH, the Maternal and Neonatal Directed Assessment of Technology (MANDATE) model, and consultations with experts. It identified five innovations with especially high potential: technologies to improve use of oxytocin, a uterine balloon tamponade, simplified dosing of magnesium sulfate, an improved proteinuria test, and better blood pressure measurement devices. Investments are needed to realize the potential of these technologies to reduce mortality.

Balloon tamponade for the management of postpartum uterine hemorrhage.

OBJECTIVE: To evaluate the use of the Bakri balloon in postpartum hemorrhage (PPH) resistant to medical treatment. METHODS: The Bakri balloon was applied to 45 women with PPH after failure of initial management. Bilateral internal iliac artery ligation (BIIAL) and hysterectomy were performed if necessary. RESULTS: The Bakri balloon was applied in 45 women; an additional BIIAL was required in nine women. The mean inflation volume of the Bakri balloon was 571±264 mL (range: 240-1300 mL). Hemostasis was achieved in 34 (75.5%) women with the Bakri balloon alone, and in six women with an additional BIIAL. The Bakri balloon was effective with additional procedures overall in 40 of 45 (88.8%) women. In 34 women with uterine atony, the Bakri balloon was successful alone in 27 (79.4%) and with an additional BIIAL in 30 (88.2%) women. An inflation volume of >500 mL was necessary in 18 women with uterine atony. CONCLUSION: The Bakri balloon may be performed as a first line of treatment for PPH resistant to uterotonic agents, and can be used not only in tertiary centers but also in limited-resource centers. The inflation volume of the Bakri balloon should be adjusted according to the type of PPH; a volume exceeding 500 mL may be necessary in uterine atony.

Bakri balloon in the management of postpartum hemorrhage: a review.

OBJECTIVE: The purpose of this review is to ascertain the indications, techniques, and the associated morbidity with the use of Bakri balloon. MATERIAL AND METHODS: A literature search using the PubMed database was conducted from 2001 to 2013. We calculated 95% confidence intervals (CIs) for complications. RESULTS: We identified 12 publications that met the inclusion criteria. Four reports provided the frequency of Bakri use during the study period, with the overall rate being 0.20% (138/69, 174; 95% CI, 0.17-0.25%). Two-thirds of use followed cesarean delivery (67%; 182/273). Uterine atony was specified as the underlying etiology of postpartum hemorrhage in 75% (9/12) of publication. The rate of balloon displacement was 10% (95% CI, 6-16%) and need for transfusion, 43% (95% CI, 32-55%). Hysterectomy was undertaken in 6% (95% CI, 4-10%). CONCLUSIONS: There is a paucity of publications on Bakri balloon. Before its utilization is recommended in guidelines, a randomized clinical trial comparing uterotonics alone versus with balloon is warranted.

A 3D-printed condom intrauterine balloon tamponade: Design, prototyping, and technical validation.

Post-partum haemorrhage is among the main causes of (preventable) mortality for women in low-resource settings (LRSs), where, in 2017, the mortality ratio was 462 out of every 100 000 live births, over 10 times higher than for high-resource settings. There are different treatments available for post-partum haemorrhage. The intrauterine balloon tamponade is a medical device that proved to be a simple and cost-effective approach. Currently, there are several balloon tamponades available, with different design and working principles. However, all these devices were designed for high-resource settings, presenting several aspects that could be inappropriate for many lower-income countries. This paper presents the results of a preclinical study aiming at informing the design, prototyping and validation of a 3D-printed intrauterine balloon tamponade concept, contributing towards the United Nation's Sustainable Development Goal 3: Good health and Well-being. Frugal engineering concepts and contextualised design techniques were applied throughout, to define the design requirements and specifications. The performance of the final prototype was validated against the requirements of the UK National Health System (NHS) technical guidelines and relevant literature, measuring the water leak and pressure drop over time, both open air and in a approximate uterus model. The resulting prototype is made up of six components, some of which are easy to retrieve, namely a water bottle, a silicone tube and an ordinary condom, while others can be manufactured locally using 3D printers, namely a modified bottle cap, a flow stopper and a valve for holding the condom in place. Validation testing bore promising results with no water or pressure leak open air, and minimal leaks in the approximate uterus model. This demonstrates that the 3D printed condom-based intrauterine balloon tamponade is performing well against the requirements and, when compared to the state of the art, it could be a more appropriate and more resilient solution to low-resource settings, as it bypasses the challenges in the supply of consumables and presents a greener option based on circular economy.

Postpartum haemorrhage management: A randomized controlled trial comparing transvaginal uterine artery clamp, vacuum-assisted uterine contraction and condom tamponade.

OBJECTIVE: While there have been numerous innovations recently for the management of postpartum haemorrhage (PPH), a limited body of research supports their application during this critical complication, which contributes significantly to maternal mortality worldwide. This randomized controlled trial (RCT) aimed to evaluate the effectiveness of three interventions - transvaginal uterine artery clamp (TVUAC), vacuum-assisted uterine contraction using a suction cannula (SC), and condom tamponade (CT) - in the management of atonic PPH. METHODS: An open-label RCT was conducted among women who delivered vaginally and developed atonic PPH at a tertiary care obstetric facility. Block randomization with sealed envelopes was used to allocate eligible participants into three interventional arms with a 1:1:1 ratio. The exclusion criteria were twin deliveries, haemodynamically unstable patients, and individuals who did not provide informed consent. The primary outcome variables assessed were blood loss post-application, total blood loss, time taken for application, and time required to achieve haemostasis within each trial arm. The secondary outcomes were the need for a second instrument or surgical intervention to control bleeding, and requirement for blood transfusion. Effectiveness outcomes were analysed as intention-to-treat, whilst safety outcomes were analysed as as-treated. RESULTS: Sixteen participants were randomized to each intervention group (n = 48). TVUAC and SC demonstrated comparable outcomes, while CT lagged in all examined parameters. Following device application, blood loss was similar in both the TVUAC (235 ± 187 ml) and SC (246.5 ± 189 ml) groups. However, following the use of CT, there was blood loss of 431 ± 427 ml, although this difference was not significant (p = 0.113). When considering total blood loss, the TVUAC group (903 ± 234 ml) showed slightly higher values than the SC group (887 ± 184 ml). However, the CT group exhibited notably higher total blood loss (1068 ± 455 ml) than the TVUAC and SC groups. In terms of application time, both TVUAC (1.8 ± 1.1 min) and SC (1.6 ± 0.9 min) significantly outperformed CT (3 ± 1.3 min) (p = 0.002). Furthermore, the time interval from the diagnosis of PPH to achieving haemostasis (defined as the time taken for active haemostasis) was significantly shorter in the TVUAC group (6 ± 4 min) and the SC group (5.7 ± 1.6 min) compared with the CT group (9.7 ± 3.8 min) (p = 0.002). CONCLUSIONS: TVUAC and SC are more effective for the management of PPH than CT. However, both TVUAC and SC have advantages and disadvantages. While these results suggest a potential preference for TVUAC and SC over CT for the management of PPH, further research is necessary to validate these findings.

Short and long-term menstrual, reproductive, and mental health outcomes after the intrauterine use of chitosan tamponade or the Bakri balloon for severe postpartum hemorrhage: an observational study.

OBJECTIVE: This retrospective follow-up study analyzes the effect of intrauterine postpartum hemorrhage (PPH) therapy on menstrual, reproductive, and mental health outcomes. METHODS: All women who delivered at a university hospital between 2016 and 2021 with PPH and who needed intrauterine therapy were included. A questionnaire on well-being, menses, fertility, and reproductive outcomes was mailed to the patients. Those who did not reply were surveyed by telephone. RESULTS: A total of 214 women treated with chitosan-covered gauze (group A) and 46 women treated with a balloon tamponade (group B) were recruited, and their short-term courses were analyzed. For long-term follow-up, 71 women of group A (33%) and 21 women of group B (46%) could be reached. A total of 89% of group A and 95% of group B had regular menstrual bleeding in the most recent 12 months; 27% (group A) and 29% (group B) were trying to conceive again, and all of them did so successfully. There were 12 deliveries, 3 ongoing pregnancies, 3 miscarriages, and 2 terminations of pregnancies (TOP) in group A and 4 deliveries, 1 miscarriage, and 2 TOPs in group B. More than half of our study participants was sorted into grade II or III of the Impact of Events Scale, indicating they experienced clinical impacts in the form of psychological sequelae. One-quarter of patients had symptoms of post-traumatic stress disorder. CONCLUSION: Chitosan gauze as well as balloon tamponade appear to have few adverse effects on subsequent menstrual and reproductive function. Women after PPH are at increased risk of long-term adverse psychological outcomes.