Oxytocin in prefilled Uniject™ injection devices for managing third-stage labor in Indonesia
Abstract
We assessed the use and acceptability of an injection device (Uniject™) prefilled with oxytocin, as part of active management of third-stage labor (AMTL) by Indonesian midwives attending home births. We interviewed 140 village midwives (bidan di desa) and 2220 mothers whose deliveries they attended during the intervention period. We completed baseline and post-intervention assessments to determine their experiences and views of oxytocin Uniject™ use. Delivery logs and supervisory reports were reviewed. The assessment was done in three rural districts and one municipality in Lombok. Injection practices and oxytocin availability did not change dramatically, although dose accuracy, use of sterile injection equipment, and proper disposal improved when the Uniject™ device was used. Midwives had little difficulty using the Uniject™ device properly; they overwhelmingly preferred it to standard needles and syringes. Postpartum hemorrhage rates did not change substantially. Oxytocin via Uniject™ holds promise for safer, more convenient use of oxytocin by trained midwives attending home deliveries, thereby potentially reducing the incidence of postpartum hemorrhage.
1 Introduction
Postpartum hemorrhage (PPH) is a major cause of maternal death in Indonesia, as well as globally. The maternal mortality ratio in Indonesia, estimated at 470 per 100 000 live births in 1995 [1], is one of the highest in the Association of South East Asian Nations (ASEAN) region and results in approximately 20 000 maternal deaths each year. For the most part, deaths due to PPH among Indonesian women are associated with a combination of factors including the high prevalence of iron-deficiency anemia (51%) [2], the low proportion (60%) of births attended by trained health professionals, and the inadequate skills and lack of availability of professional health providers to carry out appropriate obstetric emergency care.
On Lombok Island, the highest proportion of deaths among women of reproductive age is caused by hemorrhage, in particular, postpartum hemorrhage. Results from a local survey [3] recorded that 60 940 (73%) out of 83 051 deliveries in 1998/1999 were assisted by midwives; 21 012 (25%) by trained traditional birth attendants (TBAs); and 1099 (1%) by untrained TBAs. During that period, out of 5475 obstetric emergency cases noted, 3485 (64%) were due to hemorrhage; the rest were due primarily to prolonged labor, eclampsia/pre-eclampsia, and infection. Of the 118 (2.2%) that resulted in death, 78 (66%) were caused by hemorrhage. If most of the hemorrhages from this audit were postpartum, the PPH incidence rate on Lombok Island during 1998/1999 was approximately 4%.
Various studies have shown that oxytocic drugs, when routinely used in the third stage of labor, can reduce the risk of postpartum hemorrhage by approximately 40–70% [4–6]. The Mother–Baby package developed by the World Health Organisation (WHO) recommends active management of the third stage of labor (including use of oxytocin) [7]. This recommendation was also adopted by the Government of Indonesia, but significant logistic and storage constraints still prevent nationwide implementation of routine prophylactic oxytocin use. More than 70% of births occur either at home or in small health facilities [1]. Therefore, it is desirable to make it as easy and safe as possible for midwives attending home deliveries to perform routine postpartum injections of oxytocin.
The Uniject™ prefilled injection device (Uniject™ is a trademark of BD, USA), a non-reusable injection system with a sterile needle attached, prefilled with a single dose of 10 IU oxytocin, can ensure convenient and sterile administration of an accurate dose. This study was undertaken by WHO/Indonesia, the Ministry of Health (MOH) in Indonesia, and the Program for Appropriate Technology in Health (PATH) to evaluate the usefulness and feasibility of this new injection format for oxytocin.
The primary objectives for the study were to: (1) describe the availability and use of oxytocin in clinical practice related to PPH at the village level, before and after the introduction of oxytocin in Uniject™; (2) evaluate the comprehension of the training materials on the use and disposal of the Uniject™ device; and (3) assess the acceptability of the Uniject™ device among village-based midwives (bidan di desa). A secondary objective was to gather descriptive data on the magnitude of PPH encountered by the midwives.
2 Materials and methods
The study used a pre- and post-intervention design that compared perceptions and self-reported practices of midwives related to the management of the third stage of labor. Midwives were selected for inclusion in the study if they maintained a caseload of at least four deliveries per month. The intervention consisted of both training in active management of third-stage labor (AMTL), including uterine fundal massage, controlled cord traction, prompt cutting of the cord, and injection of oxytocin, and supplying oxytocin in Uniject™ devices for a 4-month period (November 1999–February 2000). Midwives were trained to give a second dose of oxytocin if they thought a woman had PPH and to refer her if necessary. Midwives estimated the rates of PPH retrospectively from their registers for the 1-year baseline period and tracked cases of PPH and use of oxytocin prospectively during the intervention period.
Materials included Uniject™ devices, oxytocin, and carrier boxes. The Uniject™ device (Fig. 1) consists of a sealed plastic reservoir with an attached fixed needle (23 gauge, 30 mm long) that came enclosed in a peel-back foil pouch. The Uniject™ device is removed from its foil pouch and activated by pushing together the needle shield and port. The needle shield is then removed, and the needle is inserted into the injection site. The dose is delivered by squeezing the reservoir until it collapses. Uniject™ devices cannot be refilled for reuse, eliminating the danger of infectious disease transmission. For this study, Uniject™ devices were filled with 10 IU of oxytocin in 1 ml of liquid. They were kept refrigerated at 2–8 °C during transport and storage, until they reached health centers. At the health center, midwives obtained a certain number of oxytocin-Uniject™ devices based on the number of deliveries they expected to attend during the month.

Uniject™ injection device.
Although the oxytocin had been validated for storage outside the cold chain for at least 1 month (allowing for monthly distribution), local health officials decided to distribute supplies of oxytocin in Uniject™ more frequently—whenever it was convenient for midwives to collect them. Each midwife was equipped with a specially designed carrier box (Fig. 2) in which to store, carry, and dispose of Uniject™ devices. The box was composed of two compartments: one for storage of new Uniject™ devices and another for disposal of used Uniject™ devices. Each month the box was to be returned to the health center to count the number of used Uniject™ devices and dispose of them through incineration.

Carrier box (with disposal compartment).
2.1 Data collection, entry, and analysis
Several procedures for collecting data from midwives were employed. The midwives completed a pretraining questionnaire that collected information about their knowledge about Uniject™ devices and AMTL, particularly in relation to PPH. The incidence of PPH over the previous 12-month period was ascertained from information collected by each midwife in her Mothers Cohort Book (delivery registry). The postimplementation questionnaire, completed by each of the midwives at the end of the intervention period, consisted of open- and close-ended questions about the use of Uniject™ devices compared with other injection devices, any functional problems with the Uniject™ device, and comprehension of the instruction sheet. A log was distributed to each midwife to record each delivery, the use of oxytocin-Uniject™ devices, the number of defective Uniject™ devices (if any), and the disposal method of used Uniject™ devices. The provincial team provided supervision to the district and health center staff and midwives using a checklist to standardize the process. A death reporting and investigation form was also distributed for use in the event that any maternal deaths should occur during the study deliveries.
Data collected from the midwives’ monthly report forms at the beginning of each month were aggregated at the health centers and sent to the district or municipality. At the district level, oxytocin-Uniject™ usage reports and logistics reports were compiled and sent to the province. Data from these two reports and the questionnaires were entered into the computer and analyzed using EPI Info 6.04 and SPSS.
2.2 Ethical review
The study protocol was approved by the Committee for Health Research Ethics (National Institute of Health Research and Development—MOH) in Indonesia and by PATH's Human Subjects Protection Committee. In the presence of a third-party witness, verbal informed consent was obtained from each pregnant woman after the midwife verbally gave her information about the study. Consent was obtained during the third-trimester antenatal visit or at the start of the delivery process.
3 Results
A total of 140 midwives from four districts on Lombok Island responded to the pretraining questionnaire. Of the initial 140 participating midwives, 127 came from 22 health centers and 13 were private-sector midwives in Mataram municipality. During the intervention phase, 138 midwives from 21 health centers recorded data on deliveries and oxytocin use. A total of 137 midwives completed the post-intervention questionnaire. Three of the midwives who participated in the pretraining questionnaire were unable to complete the study due to political disturbances in their areas of operation.
3.1 Availability and use of oxytocin
During the baseline period from July 1998 through June 1999, the midwives assisted women with 14 088 deliveries, with individual midwives varying from 16 to 368 in the year. The deliveries occurred in the mother's home (42%), in the village birthing hut (38%), at the local health center (13%), or in other unspecified locations (7%). During the 4-month intervention period, 138 midwives attended 2220 deliveries (with a range of 3–95).
Most of the midwives (96%) in the baseline survey stated that they always had oxytocin in their delivery kits and used it routinely to manage third-stage labor, while the remaining 4% stated that they had it only sometimes. The usual practice reported was to give one 1-ml (10 IU) dose after complete delivery of the baby but before the placenta was expelled. There was some variability in the number and timing of doses and the volume and actual dose of oxytocin reported. In the intervention period, oxytocin was used as part of the AMTL in all 2220 deliveries, always with a 1-ml (10 IU) dose. Approximately half the midwives (52%) attended 10–20 deliveries (using Uniject™ devices) during the intervention period; 18% attended fewer than 10 births; while the remaining 30% attended more than 20 births using Uniject™ devices.
3.2 Comprehension of the Uniject™ device training materials
Post-intervention survey results showed that the comprehension of the Uniject™ device training materials by the midwives was high. Prior to the training, slightly less than half (46%) of the 140 midwives had heard about the Uniject™ injection device, but only 16% had ever used it before (it was used with vaccines in some parts of Lombok). After training and use, most midwives identified that the Uniject™ device was sterile (100%); ready to use (98%); packaged for a single use, and unable to be reused (94%); and that the volume was equal to one dose (83%).
In addition, the majority of the midwives appeared to understand the best storage, disposal, aspiration, and activation practices of the Uniject™ device, but there was confusion about correct storage temperature. Only 7% understood that 2–3 months at ambient temperatures was acceptable, while 88% of the midwives stated that oxytocin-Uniject™ devices should always be stored in the refrigerator at 2–8 °C. Most (85%) of the midwives stated that the disposal box for used Uniject™ devices should be burned at the end of the month. Approximately half the midwives (51%) correctly stated that there was no need to aspirate with the Uniject™ device; most of the others thought aspiration was necessary and gave an incorrect explanation of how to do it. Almost all the midwives (95%) correctly stated that one should remove the needle cap of the Uniject™ device after activation. The midwives stated correctly a variety of ways to know whether or not the Uniject™ device was activated (Table 1).
Methods | Midwives citing a response (n=137) | |
---|---|---|
Number | Percent (%) | |
Needle is closer to the blister | 74 | 54 |
Uniject™ column not seen under the cap | 21 | 15 |
Oxytocin drips out after being activated | 17 | 12 |
View the oxytocin volume | 4 | 3 |
Needle and hub neck not seen | 1 | <1 |
- a An additional 15% of the midwives stated that they had no comment or another unspecified comment regarding activation.
3.3 Acceptability of the Uniject™ device
Acceptability of the Uniject™ device was assessed partly by comparison with conventional needles and syringes. In the baseline questionnaire, midwives were asked if they had any difficulties preparing or administering oxytocin at deliveries. Of the 128 who responded to the question, 32% reported no particular difficulties. Approximately 17% considered ampoules and syringes to be impractical; a similar number worried about equipment not being sterile; and 15% reported problems opening the ampoules or filling the syringes. Approximately 11% described ampoules and syringes as ‘less efficient;’ another 7% specifically mentioned difficulties preparing the injections when working alone. Three midwives mentioned concerns about getting the correct dose or picking up the wrong medicine, and four mentioned concerns about medical emergencies when they need to act quickly. Four mentioned difficulties opening the ampoules while wearing gloves.
After the 4-month intervention period, almost all the midwives identified the Uniject™ device as being easier to use than either reusable (99%) or disposable (95%) syringes. Most respondents (96%) reported that they preferred the Uniject™ device to reusable or disposable syringes, primarily because the Uniject™ device was more practical. They also were more likely to mention sterility as an advantage when comparing Uniject™ with reusable syringes, as opposed to disposable syringes (36% vs. 13%). Table 2 shows the features named by midwives as the ones they liked most about the Uniject™ device. Most of the respondents found the activation of the Uniject™ device to be easy (93%); only a few found activation moderately difficult (5%) or difficult (2%). The majority of midwives also reported the injection process to be easy (95%). In general, most midwives (72%) liked the device with no reservations, while the remaining 28% liked the device but with some reservations. A majority of the midwives (86%) stated that they would like to use the storage box (with disposal compartment) for the Uniject™ injection device in the future.
Features | Midwives citing a responsea | |
---|---|---|
(n=136) | ||
Number | Percent (%) | |
Practical | 119 | 87 |
Sterile | 43 | 32 |
Safe | 25 | 18 |
Easy to use | 23 | 17 |
- a Respondents could give multiple responses.
Undesirable product features noted by respondents included the need for the Uniject™ device to be stored in the cold chain (15 midwives), the 1-month shelf life outside the cold chain (five), clogging of the needle (four), the need to activate the device before use (one), and the limited supply of the product (two).
A large majority (91%) of the midwives reported that they had no logistical or product-related problems giving injections with the devices. In the post-intervention questionnaire, 15 midwives (11%) stated that they had come into contact with defective Uniject™ devices (19 instances in all, or 0.8% of the total), including devices that had leaks (one), ‘clogged’ needles (11), ‘expired’ product (four), dull needle (two), and loose needle (one). According to the midwives’ reports, 75 units (3.2%) ‘expired’ before they could be used, and 22 (0.9%) were ‘clogged’ or leaky and could not be used.
Client reaction to the use of the Uniject™ device was satisfactory. Of the 63 midwives who reported comments from clients who had received oxytocin injections with a Uniject™ device, 27 (43%) reported that it caused less bleeding. Other reactions of clients to the use of oxytocin in Uniject™, as reported by midwives, included absence of pain at the injection site (29%) and feeling satisfied with the method (11%). Eight percent of the midwives with comments reported that some of their clients perceived the Uniject™ needle as being too big.
In addition to a fee for delivery assistance, women who were delivering often paid for drugs (including oxytocin) and a variety of other costs. The future estimated fees for delivery services, reported by midwives in the postimplementation questionnaire, were substantially the same whether they included oxytocin in Uniject™ devices or not. These estimated fees are also very similar to the averages reported during the baseline period.
3.4 Injection safety
An impetus for introducing the Uniject™ device is to improve injection safety. In the pre-intervention period, midwives frequently reused syringes and needles. In the baseline questionnaire, only approximately half the midwives (49%) stated that they ‘always’ used a new syringe and needle for each injection, and 41% stated that they ‘sometimes’ used a new syringe and needle. Of the 58 midwives who stated that they reused their syringe and needle devices sometimes, the majority (86%) reported that they reused the syringe and needle two times, while 14% reported that they reused their injection device three times. None of the midwives reported that they reused injection devices more than three times. The specific cleaning procedures used by the midwives who reported reuse of injection devices are shown in Table 3; only 35% reported using adequate procedures such as boiling for 15 or 20 min.
Reported procedure | Midwives (n=56)a | |
---|---|---|
Number | Percent (%) | |
Boil 15 min | 17 | 30 |
Boil 20 min | 3 | 5 |
Boil (time not specified) | 21 | 38 |
Bring to boil | 4 | 7 |
Cook or steam (time not specified) | 8 | 14 |
Soak or rinse | 3 | 5 |
- a Two midwives did not respond.
Midwives were not asked to report retrospectively on needle-stick injuries during the baseline period. In the post-intervention survey, 10 of the midwives (7%) stated that they were more likely to experience a needle-stick injury with the Uniject™ device than with other syringes. Of the 10 women who reported a needle-stick injury, five experienced the stick when discarding the device into the disposal box after use, and three were stuck when they removed the needle cap. A singular instance of needle stick was experienced when the needle was being recapped. Those with needle-stick injuries had used 12–18 Uniject™ devices each during the study.
Although disposal practices were generally good to begin with, they were somewhat safer after the special disposal box was provided as 64% of the midwives reported that they placed used Uniject™ devices directly in the disposal box. Midwives cited a variety of responses in the pre-intervention questionnaire regarding current disposal practices for used injection devices, including burning and burial. Detail about decontamination practices was provided for less than half of the respondents. For example, approximately 13% of midwives put the syringes directly in a medical waste container, while 20% said they first soaked or rinsed them in bleach before burying or burning them.
3.5 Magnitude of PPH
The number and rate of PPH cases in the baseline and intervention periods are given in Table 4. Although there was no difference in the overall PPH rate, there was a statistically significant increase in the number of cases of uterine atony reported during the intervention period (2.4%) as compared to the baseline period (1.4%). Delivery assistance data from the 12-month baseline period indicate that the midwives encountered 472 cases of postpartum hemorrhage (3.4%). Just 18% of midwives did not experience any cases of PPH; they averaged 26 fewer deliveries during the year than did those who reported at least one case of PPH. Of those reporting PPH cases, 52% managed one or two cases of postpartum hemorrhage during the period, while 36% reported three to five cases of PPH.
Type of PPH | Baseline period | Intervention period | P-value |
---|---|---|---|
(n=14 088) | (n=2220) | ||
Percent (number) | Percent (number) | ||
Uterine atony | 1.4% (198) | 2.4% (53) | <0.001 |
Retention of placenta | 1.6% (219) | 1.2% (27)a | =0.26 |
Vaginal or cervical laceration | 0.3% (45) | 0.0% (0) | =0.01 |
Otherb | 0.1% (10) | 0.0% (0) | =0.43 |
Total instances | 3.4% (472) | 3.3% (73) |
- a Includes seven cases that were also uterine atony cases.
- b Identified as relating to abortion, pre-eclampsia, and placenta previa in pretraining questionnaire only.
There were no maternal deaths due to PPH during the study, although 2–3 could have been expected based on data for prior years in Lombok. Of those women receiving a second dose of oxytocin, none required referral or emergency transport.
4 Discussion
The provision of oxytocin in Uniject™ did not change the availability or use of oxytocin as much as had been expected, primarily because the majority of midwives were already using oxytocin on a regular basis during normal deliveries. The introduction of oxytocin Uniject™ did, however, increase the accuracy of dosing and the safety of injections. Data from the public sector (Food and Drug Section of the Provincial Health Office, NTB) showed that oxytocin provided through the public sector would have been sufficient for approximately 35% of expected births in 1999. Unfortunately, there was no information available about the amounts purchased through the private sector (which many midwives reported as an important source). The improvement in accuracy of dosing was modest (just 7% reported the wrong dosages initially), but it is a critical element if the benefit of the drug is to be safely realized. Injection practices were notably safer with Uniject™, since nearly half the midwives were reusing syringes previously, and only 35% of those reported using proper sterilization procedures. There does not appear to have been any misuse of oxytocin in Uniject™, since nearly all devices were individually accounted for in the monthly reports. Nor does disposal of the devices appear to have caused any problems or unsafe practices.
Very few problems occurred with the Uniject™ device itself, either in physical integrity or ease of use. The reports of ‘clogged’ needles (0.5% of the total) were probably due to incomplete activation, which might have been caused by minor manufacturing defects or by user error. The discarding of devices because of reaching the ‘expiry’ date was due to the conservative date put on study device labels when they were originally filled; subsequent laboratory testing revealed that a longer shelf life was feasible. Supervisory reports suggest that the training may need to emphasize more strongly the message about not recapping the needle after use, since a few midwives were observed recapping needles.
The Uniject™ devices were very popular with midwives, similar to the high levels of acceptance seen among vaccinators in Indonesia [8], traditional birth attendants in Bolivia [9], and family planning service providers in Brazil [10]. Training midwives to use oxytocin in Uniject™ devices as part of AMTL took only modest effort (less than 1 day of training). Client reactions were positive, similar to those reported in Bolivia and Brazil.
Concerns expressed about the limited supplies were due to the nature of the study, but ensuring an ongoing supply is indeed an important issue. Discussions with potential manufacturers are underway. Concerns raised by midwives about the need to store oxytocin in the cold chain require clarification from manufacturers regarding the effect of ambient temperature storage on shelf life and potency [11]. This will affect both acceptability and the demand for cold storage space at provincial, district, and health center levels.
Practices related to AMTL did improve as a result of the training intervention. Although oxytocin had apparently been used previously, fundal massage, cord traction, and prompt cutting were not widely practiced before the intervention. Follow-up questions about cord traction and cutting were not asked on the post-intervention questionnaire, thus limiting the study's ability to show change in that area, but fundal massage was reported as a routine practice on the monthly data forms after the training. The increase in reported cases of uterine atony may be due to heightened awareness during the study period, but the overall rate of PPH did not change. Routine use of oxytocin in correct doses may, however, reduce the need for emergency referral.
The results of this study demonstrate that oxytocin in Uniject™ is a feasible option for use in the home by trained midwives. Given that the administration of uterotonic drugs to prevent PPH is becoming the standard of care globally [12–14], and that 50–80% of births occur in the home in the developing world, the widespread use of oxytocin in Uniject™ could enable providers to have the necessary supplies to actively manage the third stage of labor at home in a manner that is safe and acceptable to themselves and their clients.
Acknowledgements
The cooperation and assistance of the following are gratefully acknowledged: the Director of Family Health Directorate, the Directorate General for Community Health/MOH, the Head of the Subdirectorate for Maternal Health, the Director for Drugs and Medical Devices Control, the Director General for FDA/MOH, the Head of NTB Health Office, the Head of NTB Province Health Service, the Head and staff of District Health Services in Lombok, Evi Kustini and Margaretha Cephas of the NTB Provincial Health Office, and the village-based and private midwives in Lombok. In addition, the Indonesian professional societies of obstetrician-gynecologists (POGI) and of midwives (IBI) gave technical advice during the study.
This study was supported by PATH with funding from the United States Agency for International Development (USAID) under the Technologies for Health (HealthTech) program (Cooperative Agreement #HRN-A-00-96-90007) and WHO/Indonesia. Additional support was received from the Ministry of Health/Indonesia and Ministry of Health/NTB; donations of supplies came from Gedeon Richter of Hungary, Aplicaciones Farmacéuticas of Mexico, and BD of the United States. The opinions expressed are those of the authors and do not necessarily reflect the views of the sponsors or WHO.